Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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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