RecruitingPhase 1Phase 2NCT06956716

Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy in Combination With PD-1 Antibody and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma


Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine approach for people with advanced bile duct cancer inside the liver (intrahepatic cholangiocarcinoma). Researchers analyze a patient's tumor to identify unique mutation targets, then create a custom mRNA vaccine designed to train the immune system to attack those specific cancer cells. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with unresectable (cannot be surgically removed) advanced bile duct cancer inside the liver - You have not yet received any systemic treatment for this cancer - Your cancer has at least one measurable lesion - Your heart, liver, kidneys, and blood counts are within acceptable ranges - You are in reasonably good overall health **You may NOT be eligible if...** - Your cancer has spread to areas outside the liver that prevent a safe biopsy - You have already received chemotherapy or other systemic treatments for this cancer - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALindividualized anti-tumor new antigen iNeo-Vac-R01 injection

The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.

DRUGGemcitabine + cisplatin (GP)

As standard chemotherapy (D1, D8 gemcitabine 1000mg/m², intravenous drip for 30 minutes, cisplatin 25mg/m², intravenous drip), once every 3 weeks

DRUGSintilimab injection

Sintilimab Injection, 200mg, intravenous infusion


Locations(1)

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06956716


Related Trials