Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07365592

Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-05-13

138

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, multicenter, phase Ib/II combined trial of sitagliptin, XELOX chemotherapy regimen, and PD-1 monoclonal antibody in the treatment of proficient mismatch repair locally advanced colorectal cancer.

CONDITIONS

Official Title

Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically diagnosed colorectal adenocarcinoma
  • Age 18 years or older and 75 years or younger
  • MRI/CT stage T3-4aNany or TanyN1-2 without distant metastasis
  • Life expectancy of at least 1 year
  • Provided informed consent and no contraindications to chemotherapy
  • Proficient mismatch repair (pMMR) status confirmed by immunohistochemistry
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Multifocal colorectal cancer
  • History of malignant tumors except basal cell carcinoma, papillary thyroid carcinoma, or carcinoma in situ
  • Unable to receive chemotherapy due to conditions like bone marrow suppression
  • Major organ diseases or severe acute infections (e.g., COPD, coronary heart disease, renal insufficiency, hepatitis, pneumonia, myocarditis)
  • American Society of Anesthesiologists (ASA) score greater than 3
  • Mental disorders, illiteracy, or communication barriers preventing understanding of the study
  • Colorectal tumor obstruction or high risk of obstruction, bleeding, or perforation
  • Peripheral sensory nerve disorder preventing oxaliplatin chemotherapy
  • Lateral pelvic lymph node metastasis
  • Pregnancy or breastfeeding
  • Inability to undergo MRI examination
  • Use of glucocorticoids for more than 3 consecutive days within 1 month before consent
  • Diabetes or impaired glucose tolerance potentially requiring drug intervention
  • Other conditions deemed inappropriate by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

J

Jun Li, MD

CONTACT

X

Xinyi Zhou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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