Vaccine treatment for colorectal cancer liver metastases
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for R0 Resection of Colorectal Cancer Liver Metastases
This study tests a new vaccine to see if it can help patients who have had surgery for colorectal cancer spread to the liver by boosting their immune system to fight any leftover cancer cells.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Chengdu/Sichuan) |
| Trial ID | NCT06545630 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of a tumor antigen-sensitized dendritic cell vaccine as an adjuvant treatment for patients who have undergone surgery for colorectal cancer liver metastases. The trial focuses on patients who have had a complete resection of their tumors and are at high risk for recurrence. Participants will receive the vaccine postoperatively to potentially enhance their immune response against any remaining cancer cells. The study aims to determine if this innovative approach can improve patient outcomes compared to standard care.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed colorectal cancer who have undergone R0 resection and are at high risk for recurrence.
Not a fit: Patients with active tumor emergencies, abnormal coagulation function, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in patients with colorectal cancer liver metastases.
How similar studies have performed: While similar approaches using dendritic cell vaccines have shown promise in other cancers, this specific application in colorectal cancer liver metastases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pathologically confirmed diagnosis of colorectal cancer； Karnofsky performance status 0-1; Patients with tumors identified by pathologic immunohistochemistry as pMMR or by genetic testing as MSS/MSI-L; Imaging diagnosis of stage IV, resection of both primary and metastatic tumors and had NED status after surgery; With a high risk of recurrence, such as liver metastasis CRS score \>3 or successful conversion therapy; Multiple peritoneal metastases after CC0; Function of the main organs is normal; Edition Patient's written informed consent Exclusion Criteria: Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities
Where this trial is running
Chengdu, Chengdu/Sichuan
- Colorectal Cancer Center, West China Hospital — Chengdu, Chengdu/Sichuan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.