Actively Recruiting
Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
Led by Zhejiang University · Updated on 2025-05-04
30
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent form
- Aged 18 to 75 years, any gender
- Imaging shows unresectable advanced intrahepatic cholangiocarcinoma
- No previous systemic or local treatment for the cancer
- Measurable lesions according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to provide fresh tumor tissue samples for sequencing analysis
- Normal heart, liver, and kidney function based on laboratory and ECG tests
- Male and female patients of childbearing age agree to use effective contraception from consent signing to 6 months after last treatment
- Able to follow study protocol and attend follow-up visits
You will not qualify if you...
- Having other active malignant tumors except certain cured cancers in disease-free state over 5 years
- History of bone marrow, organ, or hematopoietic stem cell transplantation
- Regular use of immunosuppressants within 4 weeks before screening and during study
- Active bacterial, fungal, or tuberculosis infection
- Positive for HIV, syphilis, active hepatitis B or C
- Recent herpes virus or respiratory virus infection within 4 weeks
- Uncontrolled medical conditions such as heart failure, unstable angina, arrhythmia, or severe vascular disease
- History of drug abuse, mental illness, or other factors affecting consent or study participation
- Allergies to food, drugs, vaccines, or potential immunotherapy
- Pregnant or breastfeeding women
- Investigator judgment deeming participant unsuitable or unable to complete the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
T
Tingbo Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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