At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓ECOG performance status 0-1
- ✓MRI/enhanced CT confirmed pelvic recurrence with ≥1 measurable lesion per RECIST 1.1
- ✓Distant metastases ≤5 lesions in ≤3 organs
- ✕Prior checkpoint inhibitor therapy (anti-PD-1, PD-L1, PD-L2, CTLA-4, or T cell co-stimulation pathway)
- ✕Second primary malignancy or other malignancies within 5 years (except non-melanoma skin cancer, cervical CIS, superficial bladder tumors)
- ✕HBV infection with HBV DNA ≥1×10^4/ml or HCV infection with HCV DNA ≥1×10^3/ml or liver cirrhosis
- ✕Gastrointestinal disease: active ulcers, ulcerative colitis, unresected bleeding tumors, unhealed perforation/fistula
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05628038Phase 2RecruitingUpdate OverdueUpdated 20mo ago · Completion was 18mo agoHypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +/- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)
In Brief
A Phase 2 clinical trial evaluating PD-1 antibody, Capecitabine, and 8 other interventions for Recurrent Rectal Cancer. Currently recruiting, targeting 93 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w
Capecitabine: 1000mg/m2 d1-14 q3w
400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
400 mg/m2 q2w
130 mg/m² q3w or 85 mg/m² q2w
180 mg/m² q2w and 200 mg/m² q3w
2 mg/m² q2w and 3 mg/m² q3w
400 mg/m² q2w
5 mg/kg q2w or 7.5mg/kg q3w
25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence tumor. 35-60Gy/5-8Fx irradiation for distance metastasis tumor.