The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
The study is a prospective, single-center, single-arm phase II clinical trial to evaluate the
combination of preoperative (re)irradiation, chemotherapy and immunotherapy in locally
recurrent rectal cancer. The primary endpoint is the R0 resection rate of pelvic recurrent
tumour. The secondary endpoints include the overall response rate (ORR), progression-free
survival (PFS), local recurrence free survival (LRFS), overall survival (OS), safety and
tolerability.
The enrolled patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation
(pelvic radiation history), 6 cycles of toripalimab and CAPOX, and followed by
multidisciplinary team (MDT) for decision: radical surgery, sustained treatment until
resectable or exit. The study protocol was approved by the Ethics Committee of FUSCC. All
patients provided written informed consent before recruitment. Shanghai Junshi Biomedical
Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has
purchased liability insurance for clinical trial subjects.