Personalized dendritic cell vaccine for advanced cancer after surgery
Adjuvant Treatment in Cancer Patients with Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial
This study is testing a personalized vaccine made from patients' own tumor cells to see if it can help people with advanced cancer feel better after surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sichuan University Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT04147078 on ClinicalTrials.gov |
What this trial studies
This study tests the safety and efficacy of a personalized dendritic cell vaccine for patients who have undergone surgery for locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, and colorectal cancer. Participants will have their tumor tissues analyzed to identify neoantigens, which are then used to prime dendritic cells in vitro. The vaccine will be administered subcutaneously, and both adverse events and treatment responses will be closely monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are postoperative patients with confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, or colorectal cancer who have undergone curative resection or ablation.
Not a fit: Patients with metastatic disease, co-existing malignancies, or significant immunological co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the immune response against cancer cells, potentially improving outcomes for patients with advanced cancers.
How similar studies have performed: While the approach of using personalized dendritic cell vaccines is promising, it is still considered novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation * Anticipated life time \> 3month * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Adequate organ functions Exclusion Criteria: * Any evidence of tumor metastasis or co-existing malignant disease * Tumor emergency * Abnormal coagulation condition * Contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection * Concomitant tumors * Immunological co-morbidities
Where this trial is running
Chengdu, Sichuan
- Qiu Li — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Qiu Li
- Email: liqiu@scu.edu.cn
- Phone: +86 028-85422589
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.