The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
Age ≥18 years old, male or female;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
Parallel
Capecitabine
DrugCapecitabine: 825mg/m2, bid;
Camrelizumab
DrugCamrelizumab: 200mg
CAPOX
DrugCAPOX
Involve-field irradiation
RadiationInvolve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region
Elective nodal irradiation
RadiationElective nodal irradiation: Large pelvic field
TME surgery
Procedure/SurgeryTME surgery
CR rate
CR defined as patient achieving pCR and cCR.
MPR rate
MPR defined as patients achieving a major pathological response after surgery.
R0-resection rate
R0-resection defined as patients without tumor cell infiltration in the tissue 1mm from the resection margin
Preservation rate of adjacent invaded organs
The involved organs were successfully preserved during the operation
ORR
Defined as the percentage of complete response (CR) and partial response (PR) to tumor volume reduction according to RECIST v1.1 criteria
Click on the lead sponsor to view all of their trials.
