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

Sponsor
Sun Yat-sen University
Study ID
NCT07774754
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Drug：sintilimab — DRUG
    During neo-CRT: 2 cycles of sintilimab, 200mg d1 q3w. After neo-CRT: 6 cycles of sintilimab, 200mg d1 q3w.
  • Drug：Capecitabine — DRUG
    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：Suvemcitug — DRUG
    After 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 — RADIATION
    IMRT DT: 50Gy/25Fx

Study Details

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 Dates

First listed
Aug 19, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jan 1, 2028
Completion
Sep 1, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    This study is expected to enroll 18 patients with pMMR locally advanced rectal cancer. Patients will receive long-term chemoradiotherapy (concurrent capecitabine and two cycles of sintilimab), followed by six cycles of the Capeox regimen in combination with sintilimab and Suvemcitug. Initially, 6 patients will be enrolled to receive 2 mg/kg of suvecitib for safety evaluation. After the third patient completes neoadjuvant therapy, if two or more patients develop Grade 4 acute radiation-induced rectal injury, the dose of suvecitib will be reduced to 1.5 mg/kg for re-evaluation. If two or more patients still develop Grade 4 acute radiation-induced rectal injury, the dose will be further reduced to 1 mg/kg for re-evaluation.If 1 or fewer patients develop Grade 4 acute radiation-induced rectal injury, the sample size for this cohort will be expanded to 18 patients.

Primary Outcome Measure

Serious Adverse Effects of Neoadjuvant Therapy [ Time Frame: During neoadjuvant therapy ]

Central Contacts

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