OncoMatch/Clinical Trials/NCT05628038
The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
Is NCT05628038 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for recurrent rectal cancer.
Treatment: PD-1 antibody · Capecitabine · 5FU · folinic acid · Oxaliplatin · Irinotecan · Raltitrexed · Cetuximab · Bevacizumab — The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +/- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Previous system therapy
Cannot have received: radiotherapy
Exception: allowed if >6 months prior
No prior radiotherapy within 6 month
Cannot have received: anti-PD-1 therapy
History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy
Cannot have received: anti-PD-L1 therapy
History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy
Cannot have received: anti-PD-L2 therapy
History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy
Cannot have received: anti-CTLA-4 therapy
History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy
Cannot have received: checkpoint inhibitor
History of anti-PD-1, PD-L1, PD-L2, CTLA-4 or any other specific T cell co-stimulation or checkpoint pathway targeted therapy
Lab requirements
Blood counts
Neutrophil ≥ 1.5×10^9/L, PLT ≥ 100×10^9/L (≥ 80×10^9/L in patients with liver metastasis), Hb ≥ 90g/L
Kidney function
Cr ≤ 1.5 ULN or creatinine clearance ≥ 50ml/min
Liver function
TBIL ≤ 1.5 ULN (≤ 2.5 ULN in patients with liver metastasis); AST/ALT ≤ 2.5 ULN (≤ 5 ULN in patients with liver metastasis)
Cardiac function
No history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF<50%)
Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors. Neutrophil < 1.5×10^9/L, PLT < 100×10^9/L (PLT < 80×10^9/L in patients with liver metastasis), or Hb < 90g/L; TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis. Cr > 1.5 ULN, or creatinine clearance < 50ml / min. APTT > 1.5 ULN, PT > 1.5 ULN. Serious electrolyte abnormalities. Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h. Uncontrolled hypertension: SBP >140mmHg or DBP > 90mmHg. History of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF<50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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