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NCT07127497Active, not recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
11 Aug 2025
Start date
1 Jun 2022
Primary completion date
1 Oct 2026
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
NCT number
NCT07127497

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 1 Jun 2022 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \-

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.