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Colon Cancer clinical trials

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NCT ID: NCT06253949 Recruiting - Colon Cancer Clinical Trials

Compare Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Colorectal Cancer

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

We aim comparing different outcomes between high and low tie ligation of inferior mesenteric artery in left colorectal cancer operable and elective surgeries.

NCT ID: NCT06242418 Recruiting - Colon Cancer Clinical Trials

ctDNA in Adjuvant Chemotherapy of Stage III Colon Cancer (REVISE Trial)

REVISE
Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present. Radical surgery followed by three/six months chemotherapy is the standard of care for stage III colon cancer; however, patients with different risk factors have different prognosis. The IDEA trial divided stage III colon cancer patients into low-risk (T1-3/N1) and high-risk (T4 or N2) groups, and showed that for some low-risk patients, three months chemotherapy did not decrease survival outcomes, while for some high-risk patients, the recurrence risk was still high even after six months chemotherapy. Therefore, it's worth to explore other risk stratification factors beyond T and N stage for these patients. Circulating tumor DNA (ctDNA) is derived from cancer cells and can be detected in blood. Literatures have reported that ctDNA can be used for tumor diagnosis, therapeutic monitoring, and prognosis assessment in multiple cancers, including colon cancer. The GERCOR-PRODIGE trial, an accompanying study of IDEA, reported that in the high-risk group of stage III colon cancer, patients with ctDNA-positive and receiving six months chemotherapy had similar prognosis to these with ctDNA-negative and receiving three months chemotherapy; in the low-risk group, patients with ctDNA-negative and receiving three or six months chemotherapy had similar prognosis to patients with ctDNA-positive and receiving 6 months chemotherapy, but patients with ctDNA-positive and receiving three months chemotherapy had the worst prognosis. The results of this trial suggests that ctDNA can be potentially used as a further stratification factor to guide adjuvant chemotherapy for stage III colon cancer. Several RCTs have shown that double-drug regimens chemotherapy based on oxaliplatin (FOLFOX and XELOX) can improve the prognosis of patients with stage III colon cancer. Therefore, the ESMO, NCCN, and CSCO guidelines recommend FOLFOX or XELOX for stage III colon cancer. The 2-year disease-free survival rate of these patients who received FOLFOX or XELOX chemotherapy was about 80%. It is worth to further explore how to improve the prognosis of these patients. Recently, the triple-drug regimens of oxaliplatin, irinotecan, and fluoropyrimidine (FOLFOXIRI) has been found to be superior to FOLFOX or XELOX for metastatic colorectal cancer in terms of response rate and survival. Currently, research on FOLFOXIRI plus targeted therapy in metastatic colorectal cancer is progressing rapidly, but there is little research on the use of FOLFOXIRI as adjuvant chemotherapy for stage III colon cancer. There is an ongoing international multicenter phase III RCT comparing FOLFOXIRI and FOLFOX6 adjuvant chemotherapy for high-risk stage III colon cancer patients, but it did not further stratify patients based on postoperative ctDNA status, which may result in some patients receiving excessive chemotherapy. The present study plans to enroll patients with stage III colon cancer with positive ctDNA within 1 month after surgery. These patients will receive 2 cycles of XELOX chemotherapy followed by retesting ctDNA. During the waiting period of the ctDNA results (approximately 3 weeks due to the testing time), all patients will receive another cycle of XELOX chemotherapy. If the ctDNA remains positive, the patients will be randomly assigned to receive 8 cycles of FOLFOXIRI as intensified adjuvant chemotherapy or 5 cycles of XELOX regimen as standard adjuvant chemotherapy. If the ctDNA is negative, the patients will continue to receive 5 cycles of XELOX chemotherapy. Within 3 weeks after the completion or termination of chemotherapy, ctDNA will be retested again. The aims of this study are to explore the value of ctDNA in surveillance of chemosensitivity and to preliminarily evaluate whether the intensified chemotherapy with FOLFOXIRI can increase ctDNA clearance as well as its safety in stage III colon cancer.

NCT ID: NCT06239194 Recruiting - Breast Cancer Clinical Trials

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Start date: June 12, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

NCT ID: NCT06215677 Recruiting - Colon Cancer Clinical Trials

Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

NITDC
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.

NCT ID: NCT06202131 Recruiting - Colon Cancer Clinical Trials

Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract

ctDNA-GI
Start date: November 1, 2023
Phase:
Study type: Observational

This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

NCT ID: NCT06126406 Recruiting - Breast Cancer Clinical Trials

Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) for CEA Positive Advanced Malignant Solid Tumors

Start date: November 6, 2023
Phase: Phase 1
Study type: Interventional

This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

NCT ID: NCT06065592 Recruiting - Breast Cancer Clinical Trials

Exploring Cancer-Associated Thromboembolism Prognosis Biomarkers and Polymorphisms

CAT_PB
Start date: February 1, 2019
Phase: Phase 1
Study type: Interventional

This study aims to assess biomarkers and their related polymorphisms in the context of cancer-associated thromboembolism, with a particular focus on their interaction with the immune system. The roles of immune checkpoints, inflammatory and angiogenesis factors, as well as circulating immune cells will be elucidated. Additionally, our investigation extends to the exploration of long non-coding RNAs (LncRNAs) and genes associated with the coagulation vascular system. Initially, these aspects will be evaluated in the context of colorectal cancer, with the intention to expand our research to other solid tumors. The identification of these biomarkers and genetic factors holds the potential to revolutionize therapeutic approaches for patients with cancer-associated thromboembolism, shedding light on their chemotherapy resistance. The effectiveness of combining immunotherapy with targeted inhibitors like Palbociclib and anticoagulants such as Rivaroxaban, among other potential interventions, will be assessed. This study aims to make significant contributions to the understanding of these critical aspects, ultimately leading to the development of more effective treatment strategies for cancer patients.

NCT ID: NCT06051695 Recruiting - Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

EVEREST-2
Start date: April 3, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose of A2B694 that is safe for patients Phase 2: Does the recommended dose of A2B694 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 and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen A2B694 Tmod CAR T cells at the assigned dose

NCT ID: NCT06050447 Recruiting - Colorectal Cancer Clinical Trials

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.

NCT ID: NCT06014372 Recruiting - Colon Cancer Clinical Trials

Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Start date: July 1, 2023
Phase: Phase 2
Study type: Interventional

There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR colorectal cancer can derive benefits from immunotherapy in the management of advanced colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy, resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this particular patient population. Envafolimab monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses noteworthy practical and societal value in the context of exploratory clinical research on neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The objective of this study is to evaluate the safety and efficacy of envafolimab monoclonal antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to investigate the effectiveness and safety of envafolimab monoclonal antibody in combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.