The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Locally Advanced Rectal Cancer
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant
short-course radiotherapy in locally advanced rectal cancer (LARC). Patients are randomly
assigned into two prospective cohorts: consolidation cohort and induction cohort.
Consolidation cohort: A total of 65 patients will receive 5*5Gy short-course radiotherapy,
followed by 6 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody,
finally receive the total mesorectal excision (TME). Induction cohort: A total of 65 patients
will firstly receive 2 cycles of CAPOX chemotherapy and PD-1 antibody, then receive 5*5Gy
short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody,
finally receive the TME surgery. The rate of pathological complete response (pCR), long-term
prognosis and adverse effects will be analyzed.