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

RECRUITINGPhase 1/2Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University
Actively Recruiting
PhasePhase 1/2
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Started2026-04-09
Est. completion2029-12-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* Pathologically diagnosed colorectal adenocarcinoma
* Age ≥18 years old and ≤75 years old
* MRI/CT stage T3-4aNany and TanyN1-2, without distant metastasis
* Life expectancy of 1 year The above
* Informed consent, no contraindications to chemotherapy exist
* pMMR diagnosed by IHC

Exclusion Criteria:

* Refused to participate in this study
* Multifocal colorectal cancer
* Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ
* Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc
* Major organ diseases (such as but not limited to COPD, coronary heart disease and renal insufficiency, etc.) acute attack and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.),
* ASA score\> 3
* Mental disorder or illiteracy or language and communication barriers cannot understand the research plan
* Colorectal tumor has obstruction or high risk of obstruction and or there is bleeding and/or perforation
* Peripheral sensory nerve disorder, unable to receive oxaliplatin chemotherapy
* Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery)
* Pregnancy or breastfeeding
* Unable to accept MRI examination
* Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form
* Diabetes or impaired glucose tolerance who may require drug intervention
* Other scenarios deemed inappropriate by the investigators

Conditions2

CancerColorectal Cancer

Interventions4

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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