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Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06956716•Zhejiang University

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;
•2. Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;
+17 more criteria

Exclusion Criteria

•If the subject meets any of the following criteria, he/she will be excluded from this study:
•1. Those who suffer from other malignant tumors at the same time, but have been cured of basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc., have been in a disease-free state for more than 5 years or are considered by the researchers to be less likely to relapse;
•2. Those who have received a history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
•3. Those who are accompanied by immunosuppressants, that is, those who need to take immunosuppressants regularly 4 weeks before the screening period and during the clinical study, including but not limited to the following situations: those with severe asthma, autoimmune diseases or immunodeficiency, those who are treated with immunosuppressive drugs, and those with a known history of primary immunodeficiency; but type 1 diabetes, autoimmune-related hypothyroidism requiring hormone treatment, and vitiligo and psoriasis that do not require systemic treatment are excluded;
•4. Active bacterial or fungal infection confirmed by clinical diagnosis; active tuberculosis or history of tuberculosis;
•5. Positive test results for human immunodeficiency virus (HIV) antibody, positive test results for Treponema pallidum (TP), active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA), active hepatitis B;
•6. Herpes virus infection (except for those with scabs for more than 4 weeks); respiratory virus infection (except for those who have recovered for more than 4 weeks);
•7. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases that the investigator considers unsuitable for inclusion;
•8. History of drug abuse, clinical, psychological or social factors that affect informed consent or research implementation; history of mental illness;
•9. History of food, drug or vaccine allergy, or other potential immunotherapy allergy considered by the investigator.
+2 more criteria

Locations (1)

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 9, 2025

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2028

Last Updated

May 4, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Intrahepatic Cholangiocarcinoma

Interventions

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

BIOLOGICAL

Gemcitabine + cisplatin (GP)

DRUG

Sintilimab injection

DRUG

Contacts

Tingbo Liang

CONTACT

+8619941463683 liangtingbo@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria

Exclusion Criteria

Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)

Calcitriol in Advanced Intrahepatic Cholangiocarcinoma