Endoscopic Resection of Gastrointestinal Neoplasms
NCT04780256 · Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm
RecruitingThe study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.
Phase—
TypeObservational
Age18 Years – 100 Years
WhereReggio Emilia, RE, Italy
SponsorAzienda USL Reggio Emilia - IRCCS
▾Tap for detailsClick for full details — eligibility, all locations, contacts Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.
NCT06640166 · Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumor
RecruitingThe aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line.
PhasePhase 2
TypeInterventional
Age18 Years
WhereMilan, Italy + 2 more
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study to Evaluate Efficacy and Safety of Serplulimab(HLX10) Combined With Bevacizumab(HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
RecruitingThis is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years – 75 Years
WhereGuangzhou, Guangdong, China + 4 more
SponsorShanghai Henlius Biotech
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
NCT03539822 · Gastric Cancer, Esophageal Adenocarcinoma, Hepatocellular Carcinoma
RecruitingThe investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereWestwood, Kansas, United States + 1 more
SponsorAnwaar Saeed
▾Tap for detailsClick for full details — eligibility, all locations, contacts LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
NCT06848465 ·
Colorectal Cancer, Liver Metastasis, LDRT
RecruitingIn recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
PhasePhase 1
TypeInterventional
Age18 Years – 80 Years
WhereChongqing, Chongqing Municipality, China + 1 more
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Liver Transplantation and Colorectal Cancer
NCT01479608 ·
Colorectal Cancer, Liver Metastasis
RecruitingColorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated. The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results. The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection. The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.
PhaseNA
TypeInterventional
Age18 Years
WhereOslo, Norway
SponsorOslo University Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
NCT07208786 ·
Colorectal Cancer, Colorectal Surgery, Complications
RecruitingEvaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereNanchong, Sichuan, China
SponsorNanchong Central Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
RecruitingThe main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).
PhasePhase 2
TypeInterventional
Age18 Years – 130 Years
WhereScottsdale, Arizona, United States + 75 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance
NCT06983639 · Colorectal Neoplasms
RecruitingFrom observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.
PhaseNA
TypeInterventional
Age40 Years – 75 Years
WhereArendal, Agder, Norway
SponsorSorlandet Hospital HF
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
RecruitingThe purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication. This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC). All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles. Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 8 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy
NCT06055439 · Neuroendocrine Tumors,
Colorectal Cancer, Gastric Cancer
RecruitingThe goal of this clinical trial is to evaluate CHM-2101, an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal (GI) cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 85 Years
WhereAtlanta, Georgia, United States + 3 more
SponsorChimeric Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
NCT07023731 · KRAS G12D Mutation, Advanced Solid Cancer
RecruitingThis is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806. Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is called intravenous (IV) infusion. This study will include 2 parts. In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included. In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 13 more
SponsorArvinas Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer
RecruitingAcetylsalicylic acid (ASA) seems the ideal colorectal cancer (CRC) chemoprevention agent. Several ongoing trials are testing the effect of ASA as co-therapy in CRC. The mechanisms of action, the appropriate dose and the ideal target population are unknown. The investigators have demonstrated that doses of 100 mg of ASA induce direct and partial but persistent acetylation of the cyclooxygenase (COX) isoenzyme COX-1 in the normal colorectal mucosa. The primary objective is to perform a study of aspirin by using a proteomic assay for comparing platelet COX-1 and CRC mucosal COX-1 after different doses of ASA. Secondary objectives are: the measurement of prostaglandin E2 (PGE2) and phosphorylated S6 protein (p-S6) levels in CRC mucosa, the assessment of indirect biomarker of aspirin action (serum thromboxane B2 (TXB2) and urinary levels of 11-dehydro-TXB2 (TX-M)), the evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M). Methods: Phase II randomized clinical trial in 60 patients with newly diagnosed CRC in 3 groups of 20 patients receiving 100 or 300 mg/day, or 100 mg/12 hours of enteric-coated ASA for 3±1 weeks, prior to definitive treatment by surgery. Main outcome: Acetylation of COX-1 and COX-2. Eicosanoid levels in target organs. Expected results: Evidence for the current uncertainty about the mechanisms of action and the dose required to obtain the best chemopreventive effect with ASA in CRC. Confirm acetylation of COX as a key biomarker of efficacy with ASA.
PhasePhase 2
TypeInterventional
Age18 Years – 79 Years
WhereZaragoza, Zaragoza, Spain
SponsorInstituto de Investigación Sanitaria Aragón
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
RecruitingGenetic testing can alter therapy and surgical management for cancer patients and is therefore indicated as a first-line test for many newly diagnosed patients, including breast, ovarian, pancreatic, prostate and colon/GI patients. To reduce pressure on already constrained genetics clinics across Canada, some cancer centres are 'mainstreaming' genetic testing - whereby genetic testing is initiated and mediated by oncologists without traditional pre-test genetic counseling (GC) often using some form of paper-based patient pamphlets or videos. There is no standard, evidence-based approach to mainstreaming, leading to significant practice variation, a lack of coordinated care and ultimately, negative psychological impacts on patients. Digital solutions can address these gaps by providing a standardized, coordinated and patient-centered approach to deliver cancer genetic education. However, digital solutions for providing cancer genetics services are uncommon and clinical-effectiveness and service delivery outcomes have not been well-assessed. This study will test a digital mainstreaming platform called the Genetics Adviser for Mainstream care to assess its effectiveness in improving psychological outcomes and patient-centred care for mainstream cancer patients compared to standard of care.
PhaseNA
TypeInterventional
Age18 Years
WhereToronto, Ontario, Canada + 1 more
SponsorUnity Health Toronto
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
NCT06682793 · Solid Tumor, Adult,
Colorectal Cancer, Non-Small Cell Lung
RecruitingThe goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 9 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts AB122 Platform Study
NCT04999761 · Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma,
Colorectal Cancer RecruitingThis is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAichi, Japan + 8 more
SponsorTaiho Pharmaceutical Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
NCT03280511 · Peritoneum Cancer, Peritoneal Carcinomatosis, Peritoneal Metastases
RecruitingIn this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereOdense, Denmark
SponsorMichael Bau Mortensen
▾Tap for detailsClick for full details — eligibility, all locations, contacts Liquid Biopsy Evaluation and Repository Development at Princess Margaret
RecruitingThe objective of this protocol is to develop an institution-wide liquid biopsy protocol that will establish a common process for collecting blood and corresponding archived tumor specimens for future research studies at the University Health Network's Princess Margaret Cancer Centre. Circulating cell-free nucleic acids (cfNA), including cell-free DNA (cfDNA) and cell-free RNA (cfRNA), are non-invasive, real-time biomarkers that can provide diagnostic and prognostic information before cancer diagnosis, during cancer treatment, and at disease progression. Cancer research scientists and clinicians at the Princess Margaret are interested in incorporating the collection of peripheral blood samples ("liquid biopsies") into research protocols as a means of non-invasively assessing tumor progression and response to treatment at multiple time points during a patient's course of disease.
Phase—
TypeObservational
Age18 Years
WhereToronto, Ontario, Canada
SponsorUniversity Health Network, Toronto
▾Tap for detailsClick for full details — eligibility, all locations, contacts Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques
NCT07035587 · Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
RecruitingThis is a combined prospective and retrospective observational study aiming to validate a highly sensitive and specific blood-based method for the early diagnosis and post-treatment monitoring of multiple cancers. The study leverages a newly developed sequencing method to improve the detection of circulating tumor DNA (ctDNA) in blood, focusing on enhancing sensitivity and specificity in clinical applications. The study targets patients with ovarian, lung, pancreatic, colorectal, esophageal, breast, kidney, bladder, and gastric cancer, as well as healthy controls with asymptomatic gallstones, benign polyps, or individuals undergoing routine medical screening. Blood samples will be analyzed for cell-free DNA (cfDNA), RNA, and protein profiles. A key objective is to determine how much the newly developed method increases the sensitivity and specificity of ctDNA detection, especially in early-stage cancers and minimal residual disease (MRD) after treatment. The method evaluates the variant allele frequency (VAF) of ctDNA to detect residual disease and track tumor dynamics. Serial blood sampling will be conducted before and after surgery or chemotherapy and during follow-up outpatient visits in cancer patients, while one-time sampling will be done for controls. Additionally, tissue biopsies collected during surgery will be used to analyze concordance between tumor-specific mutations and those found in ctDNA. Primary outcome measures include quantitative differences in ctDNA or RNA levels between cancer and control groups. Secondary outcomes assess the clinical correlation between changes in ctDNA VAF and patient outcomes such as recurrence and survival. Statistical tools including ROC curve analysis, Cox regression, and log-rank tests will be used to quantify performance. This study seeks to establish a clinically robust, non-invasive diagnostic tool that enables earlier detection and more precise treatment decisions, while potentially reducing physical, psychological, and socioeconomic burdens related to cancer care.
Phase—
TypeObservational
Age19 Years
WhereSeoul, South Korea
SponsorYonsei University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer
NCT07462650 ·
Colorectal Cancer Metastatic, Adenocarcinoma of Colon
RecruitingThis Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy/biomarker signals) will be selected for dose expansion.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 75 Years
WhereShenzhen, Guangdong, China
SponsorBeijing Biotech
▾Tap for detailsClick for full details — eligibility, all locations, contacts