Clinical trial · Interventional
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
NCT05914389CI-TRIAL-00068649ICONICrecruitingPhase 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 study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon 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 |
|---|---|---|---|
| Colon Neoplasm | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-L1 Monoclonal Antibody | Drug | Anti-PD-L1 Monoclonal Antibody | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Clostridium butyricum | Drug | — | UNRESOLVED |
| Colectomy | Procedure | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard chemotherapy control cohort
- description
- Patients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Standard chemotherapy control cohort and continued with two more cycles of Capox chemotherapy. Then, these patients will receive curative surgery for colon cancer.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Procedure: Colectomy
- type
- EXPERIMENTAL
- label
- Enhancement regimen of combined Anti-PD-L1 monoclonal antibody
- description
- Patients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Enhancement regimen of combined Anti-PD-L1 monoclonal antibody and continued with two more cycles of Capox chemotherapy along with the reduced dosage of Anti-PD-L1 monoclonal antibody. Then, these patients will receive curative surgery for colon cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old and ≤75 years old. * Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma. * The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination. * Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis. * Life expectancy is expected to be more than 1 year. * First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications. * Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent. Exclusion Criteria: * Refused to participate in this study. * Multifocal colorectal cancer. * History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers. * Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression. * Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \> 3 points. * Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol. * Tumor obstruction or high risk of obstruction, bleeding, and/or perforation. * Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy. * Pregnancy or lactation. * Unable to undergo enhanced CT examination or having comorbidities requiring the use of glucocorticoid therapy. * Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form. * CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis. * Other situations in which the researcher deems unsuitable for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.