Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.
Age: 18~75 years old, no gender limit;
Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR/MSS.
The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) "Bad": cT3c/d or very low localisation levators threatened, MRF clear; cT3c/d mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) "Advanced": cT3 with any MRF involved, any cT4a/b, lateral node+.
Recurrent rectal cancer;
Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%;