Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Safety and Efficacy Evaluation of Neoadjuvant Chemotherapy Without Radiotherapy Combined With Sintilimab for Locally Advanced Rectal Cancer: Short-term Results of a Single-arm Phase 2 Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
November 21, 2025
March 1, 2025
4.3 years
August 11, 2025
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy
Objective response rate refers to the proportion of patients who achieve complete response (CR) and partial response (PR) among the treated patients within a certain period of time.
From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy
Study Arms (1)
the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab c
EXPERIMENTALSintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses
Interventions
Sintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2025
First Posted
August 17, 2025
Study Start
June 1, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
November 21, 2025
Record last verified: 2025-03