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

NCT07774754 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-19

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-01-01
Completion
2031-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774754 on ClinicalTrials.gov