Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma.
| Condition(s) | Advanced Intrahepatic Cholangiocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma. |
| Who can participate | Inclusion Criteria: * (1) Subjects who meet all the following inclusion criteria will enter the pre-screening stage of this study and undergo the lesion puncture process: 1. Voluntarily sign the informed consent form; 2. Aged ≥18 years and ≤75 years, regardless of gender; 3. Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma; 4. Have not received systemic or local treatment. 5. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis; 8. Normal function of the main organs of the heart, liver and kidney: 1. QTc (correct |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2025-04-09 |
| NCT ID | NCT06956716 |
| Official listing | https://clinicaltrials.gov/study/NCT06956716 |