RecruitingPhase 2NCT06525428

Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

A Prospective, Two-cohort Phase II Trial of Standard Systemic Therapy in Combination With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer


Sponsor

Fudan University

Enrollment

96 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

TORCH-M is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of standard systemic therapy in combination with high/low-dose radiotherapy plus toripalimab in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will first receive one cycle of standard systemic therapy and toripalimab, followed by high/low-dose radiotherapy, and then continue with standard systemic therapy and toripalimab.The survival benefits, response rates, and adverse effects will be analyzed.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a targeted radiation treatment (stereotactic body radiotherapy, SBRT) plus an immunotherapy drug (toripalimab) to standard chemotherapy can improve outcomes for patients with metastatic colorectal cancer. It focuses on a subtype of colorectal cancer (MSS/pMMR) that historically responds poorly to immunotherapy alone. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic colorectal cancer (the MSS/pMMR subtype) - You have at least one tumor site that can be treated with SBRT - You are starting first-line treatment OR your cancer has progressed after one round of treatment - Your blood counts, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - Your blood counts are too low (anemia, low platelets, or low white cells) - You have severe liver dysfunction or abnormal kidney function - You have active gastrointestinal ulcers, bleeding problems, or uncontrolled high blood pressure - You have had a recent blood clot, heart attack, or heart failure within the past 6 months - You have previously received immunotherapy (anti-PD-1 or anti-CTLA-4) - You have active hepatitis B or C - You are pregnant or breastfeeding 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

DRUGstandard systemic therapy combined with high/low-dose radiotherapy plus toripalimab

First-line standard systemic therapies in cohort A include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only), FOLFIRINOX+ bevacizumab. Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT), FOLFIRI/irinotecan+raltitrexed/irinotecan/+bevacizumab, FOLFIRI/irinotecan+raltitrexed/irinotecan/+cetuximab (KRAS/NRAS/BRAF WT), based on the previous first-line chemotherapy and adverse events. Toripalimab will be given at 240 mg q3w. Radiotherapy regimes include 4-8 fractions of 4-12Gy via SABR or hypofractionated radiotherapy (HFRT) and 5 fractions of 0.5-2Gy via LDRT


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06525428


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