Clinical trial · Interventional
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
NCT07365592CI-TRIAL-00111383Neo-CDrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Sitagliptin (DPP4 inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XELOX+sitagliptin+anti-PD-1
- description
- XELOX (oxaliplatin + capecitabine), sitagliptin and PD-1 monoclonal antibody
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Anti-PD-1 monoclonal antibody
- Drug: Sitagliptin (DPP4 inhibitor)
- type
- ACTIVE_COMPARATOR
- label
- XELOX
- description
- XELOX (oxaliplatin + capecitabine)
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes (3)
- measure
- Adverse events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.