RecruitingPhase 2NCT06547203

Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study


Sponsor

Sun Yat-sen University

Enrollment

34 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer drugs — cetuximab, irinotecan, and toripalimab — for people with advanced colorectal cancer that started in the right side of the colon and has spread to other parts of the body. Researchers want to see if this triple-drug approach works better for patients whose tumors have specific genetic characteristics. **You may be eligible if...** - You have been diagnosed with colorectal cancer (adenocarcinoma) that originated in the right colon and has spread (metastatic) - Your tumor has been tested and found to be "RAS/BRAF wild-type" (a specific genetic profile) - You have already received prior chemotherapy treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil, and your cancer progressed - You have never received anti-EGFR or PD-1 immunotherapy drugs - Your blood counts, liver, and kidney function are within acceptable ranges - You have a reasonable level of physical function (able to care for yourself) **You may NOT be eligible if...** - You have had a heart attack or stroke in the past 6 months - You have uncontrolled infections, severe diabetes, or serious heart problems - You have brain tumors or brain metastases - You have had another cancer in the past 5 years (except certain skin or cervical cancers) - You are pregnant or breastfeeding - You have an active autoimmune disease or history of organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCetuximab

Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks

DRUGToripalimab

Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks.

DRUGIrinotecan

Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06547203


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