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%;
Single group
nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W
Other interventionRadiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.
Complete response rate (CR)
defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
Disease-Free Survival (DFS)
1/2/3 years disease-free survival
Recurrence -Free Survival (RFS)
1/2/3 years recurrence -free survival
Overall Survival (OS)
3 years overall survival
Local Recurrence (LR) Rate
2-year local recurrence rate
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This trial is not recruiting at the moment. You can still explore other options:
