NCT07365592 Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC
| NCT ID | NCT07365592 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2026-04-09 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 138 participants in total. It began in 2026-04-09 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07365592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07365592 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07365592 currently recruiting?
Yes, NCT07365592 is actively recruiting participants. Contact the research team at 2307016@zju.edu.cn for enrollment information.
Where is the NCT07365592 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07365592 clinical trial?
NCT07365592 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 138 participants.
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