About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Capecitabine
- Camrelizumab
- CAPOX
- Involve-field irradiation
- Elective nodal irradiation
- TME surgery