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NOT YET RECRUITING
NCT07774754
PHASE2

Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-09-01

Completion Date

2031-09-01

Last Updated

2026-08-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Drug:sintilimab

During neo-CRT: 2 cycles of sintilimab, 200mg d1 q3w. After neo-CRT: 6 cycles of sintilimab, 200mg d1 q3w.

DRUG

Drug:Capecitabine

During 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

Drug:Suvemcitug

After neo-CRT: 6 cycles of suvecitib (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, every 3 weeks.

RADIATION

Radiation: Neoadjuvant Radiotherapy

IMRT DT: 50Gy/25Fx

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China