A Phase 2 interventional study of Short-course radiotherapy and PD-1 antibody (Toripalimab) in Early Low Rectal Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
Radiation: Short-course radiotherapy · Drug: PD-1 antibody (Toripalimab) · Drug: Oxaliplatin · Drug: Capecitabine
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
Radiation: Long-course radiotherapy · Drug: Oxaliplatin · Drug: Capecitabine
Short-course radiotherapy: 25Gy/5Fx
Also known as: SCRT
Toripalimab 240mg d1 q3w
Also known as: Toripalimab
Long-course radiation: 50Gy/25Fx
Also known as: LCRT
Oxaliplatin: 130mg/m2 d1 q3w
Xeloda
Also known as: Xeloda
complete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
Time frame: 1 month after the surgery or the decision of W&W
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy
Organ preservation rate
Organ preservation rate
Time frame: from date of receiving neoadjuvant therapy, assessed up to 3 years
3 year disease free survival rate
Rate of 3 year disease free survival
Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year local recurrence free survival rate
Rate of 3 year local recurrence free survival
Time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
3 year overall survival rate
Rate of 3 year overall survival
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
3 year Quality of Life
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
Started Apr 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.
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Studies of the drug tested here: Toripalimab