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Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT07750951 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-08-06

No results posted yet for this study

Summary

Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer

Primary objectives:

Pathological complete response (pCR) rate;

Secondary objectives:

Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);

Conditions

  • MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma

Interventions

DRUG

Cindilimab、IBI310、Capecitabine、Oxaliplatin

A. Neoadjuvant treatment phase The total treatment duration was 6 weeks PD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w B. Surgical treatment stage All patients underwent preoperative evaluation within 4-6 weeks after the end of neoadjuvant therapy, * CCR: waiting for observation follow-up; * yct0-2n0m0: local resection follow-up; * yct3-4a or n+:tme- follow-up.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2026-11-30
Completion
2027-04-30

Countries

  • China

Study Locations

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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 NCT07750951 on ClinicalTrials.gov