This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.
Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.
If, following completion of neoadjuvant therapy, the subject has not achieved cCR/near-cCR status, TME surgery or other therapeutic surgery shall be performed; the interval between the final dose of suvectitumab and surgery should be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options shall be discussed with the patient. The adjuvant treatment regimen following surgery shall be determined by the investigator based on the patient's pathological results.
1) Aged 18-75 years;
1) Failure to sign an informed consent form;
Single group
Drug：sintilimab
DrugDuring neo-CRT: 2 cycles of sintilimab, 200mg d1 q3w. After neo-CRT: 6 cycles of sintilimab, 200mg d1 q3w.
Drug：Capecitabine
DrugDuring neo-CRT: capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks, 2 cycles. After neo-CRT: 6 cycles of capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks.
Drug：Suvemcitug
DrugAfter neo-CRT: 6 cycles of suvecitib (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, every 3 weeks.
Radiation: Neoadjuvant Radiotherapy
RadiationIMRT DT: 50Gy/25Fx
Serious Adverse Effects of Neoadjuvant Therapy
Complete response (CR) rate
Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).
major pathological response and tumor regression grade
R0 rate
Long-Term Quality of Life
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be linearly transformed to a 0-100 scale. For the global health status/quality-of-life scale, a higher score represents a better level of global health status and quality of life. Changes from baseline will be evaluated during follow-up.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
