NCT07365592RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 9 Apr 2026
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT07365592
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 138
- From 9 Apr 2026 to the primary completion date, 1 Dec 2029
- 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.
Prior treatment
- Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc
- Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form
Other illness
- Multifocal colorectal cancer
- Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ
- 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.),
- 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
Lab values
- Diabetes or impaired glucose tolerance who may require drug intervention
Other
- Refused to participate in this study
- ASA score\> 3
- Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery)
- Pregnancy or breastfeeding
- Unable to accept MRI examination
- Other scenarios deemed inappropriate by the investigators
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.