Clinical trial · Interventional
Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer
Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial
NCT06215677CI-TRIAL-00118679NITDCactive not recruitingPhase 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)
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Immunotherapy | — | UNRESOLVED | — |
| Mismatch Repair Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant immunotherapy
- interventionNames
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- the rate of R0 resection
- timeFrame
- Tumour specimen evaluated within 2 weeks after surgery
- description
- No tumor infiltration within 1 mm of the surgical margins
Secondary outcomes (4)
- measure
- Pathological complete response (pCR)
- timeFrame
- Tumour specimen evaluated within 2 weeks after surgery.
- description
- Number of patients with pCR evaluated according to the Mandard tumour regression grading system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75 years; 2. ECOG score 0-2; 3. Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR; 4. Tumor located in cecum, ascending colon, transverse colon and sigmoid colon; 5. Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration; 6. No evidence of distant metastasis; 7. Newly treated patients who have not received treatment including chemotherapy and surgery; 8. Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery; 9. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent. Exclusion Criteria: 1. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years; 2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women; 3. Patients with a history of severe mental illness, immune disease, hormone medication; 4. Patients contraindicated by immunotherapy or surgery; 5. Participated in other clinical researchers in the past 3 months; 6. Any other circumstances that the investigator considers inappropriate for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.