A Prospective, Two-cohort Phase II Trial of Standard Systemic Therapy in Combination With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
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.
• Age between18 and 75 years old.
• An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
• At least one evaluable metastatic lesion for radiotherapy and evaluation according to RECIST 1.1.
• Treatment naive (first-line cohort) and progressed on after first-line therapy or stopped first-line therapy due to unacceptable toxic effects (second-line cohort).
• Prior radiotherapy completed at least 4 weeks before enrollment.
• Adequate bone-marrow, hepatic, and renal function: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST≤2.5 ULN, Cr≤1 ULN.
• Sign the informed consent and have good compliance.