NCT06956716View on ClinicalTrials.gov

Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2028

Conditions
Advanced Intrahepatic Cholangiocarcinoma
Interventions
BIOLOGICAL

individualized 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.

DRUG

Gemcitabine + cisplatin (GP)

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

DRUG

Sintilimab injection

Sintilimab Injection, 200mg, intravenous infusion

Trial Locations (1)

310003

RECRUITING

the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

Hangzhou Neoantigen Therapeutics Co., Ltd.

INDUSTRY

lead

Zhejiang University

OTHER