Actively Recruiting
Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection
Led by Yongyi Zeng · Updated on 2025-05-15
10
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma
CONDITIONS
Official Title
Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign informed consent and comply with study visits and procedures
- Age 18 to 75 years, any gender
- Pathologically confirmed intrahepatic cholangiocarcinoma
- Underwent surgical removal with high-risk recurrence factors (positive margins, lymph node metastasis, vascular or nerve invasion, tumor >5cm, stage IB-IIIB)
- No prior systemic adjuvant therapy
- Child-Pugh grade A liver function
- ECOG performance status 0-1
- If hepatitis B positive, HBV-DNA <2000 IU/mL with at least 1 week of antiviral treatment before study and willing to continue
- If hepatitis C virus (HCV) positive, receiving antiviral treatment as per guidelines
- Provide fresh or archived tumor tissue for sequencing and vaccine preparation
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function with specified lab values
- Fertile women must agree to contraception and negative pregnancy test before treatment
- Fertile men must agree to contraception and not donate sperm during study period
You will not qualify if you...
- Diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, hilar cholangiocarcinoma, or gallbladder cancer
- Other active malignant tumors within 5 years except certain cured localized tumors
- Current or history of interstitial lung disease needing steroids, active pneumonia, or severe lung impairment
- Active or history of autoimmune diseases that may relapse (except controlled thyroid disorders and some skin conditions)
- Use of immunosuppressants or systemic steroids >10mg/day prednisone equivalent within 2 weeks before study
- Active infections or unexplained fever >38.5°C within 1 week before study
- Immune deficiency such as HIV infection
- Received or planned to receive live vaccines within 4 weeks before first dose
- Significant bleeding or bleeding disorders within 6 months before study
- Major arterial thromboembolic events within 6 months before study
- Uncontrolled heart diseases or significant arrhythmias
- Uncontrolled hypertension or major vascular diseases within 6 months
- Severe wounds, ulcers, fractures, or recent major surgery within 4 weeks
- Inability to swallow pills or gastrointestinal absorption issues
- Intestinal obstruction or related symptoms within 6 months before study
- Use of strong CYP3A4/CYP2C19 inducers or inhibitors within 2 weeks before study
- Prior neoantigen vaccine treatment or allergy to chemotherapy, targeted drugs, or excipients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
Y
Yongyi Zeng, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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