Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC
A Phase Ib/II Study of Neoadjuvant Chemotherapy Combined With Anti-PD-1 Antibody and DPP4 Inhibitor Sitagliptin for Locally Advanced pMMR Colorectal Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University
138 participants
Apr 9, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria15
- 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
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Interventions
Oxaliplatin 130mg/m2 for inducing chemotherapy in Day 1 every 3 weeks and repeat for two cycles.
Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy in Day 1 to Day 14 every 3 weeks and repeat for 2 cycles.
Anti-PD1 antibody 200mg/m2 in Day 1 after oxaliplatin Chemotherapy. Repeat every 3 weeks for 2 cycles.
Oral sitagliptin twice daily combined with oxaliplatin chemotherapy in Day 1 to Day 14 every 3 weeks and repeat for 2 cycles. In the phase Ib study, sitagliptin set at three dose groups: 100 mg/day, 200 mg/day, and 400 mg/day, and the primary endpoint of Ib study is to determine the DLT and recommended phase II dose (RP2D). The appropriate dose level of sitagliptin will be set based on the result of Ib study.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07365592