Actively Recruiting
Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT
Led by Yongyi Zeng · Updated on 2025-09-29
33
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.
CONDITIONS
Official Title
Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and able to comply with scheduled visits and procedures
- Age 18 to 75 years, any gender
- Diagnosed with hepatocellular carcinoma (HCC) per China's guidelines or biopsy, with at least one measurable lesion
- Presence of portal vein tumor thrombus (PVTT) type I, II, or III, with a resectable primary tumor
- Child-Pugh Class A liver function
- ECOG Performance Status of 0 or 1
- No prior antitumor treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy
- For hepatitis B virus (HBV) infection, HBV-DNA must be ≤2000 IU/mL or antiviral therapy started before treatment; continuous antiviral treatment during study for HBV positive patients; antiviral treatment for hepatitis C virus (HCV) RNA positive patients as per guidelines
- Ability to provide a fresh tumor biopsy sample during screening (waivable after medical monitor discussion) and blood samples for immune monitoring
- Expected survival of at least 12 weeks
- Adequate organ and marrow function defined by hematology, liver, renal, and coagulation lab values as specified
- Females of childbearing potential must use contraception or abstain from heterosexual intercourse from consent until 120 days after last study drug dose, have a negative serum HCG test before treatment, and not be breastfeeding
- Males with partners of childbearing potential must use contraception or abstain from heterosexual intercourse and not donate sperm from consent until 120 days after last study drug dose
You will not qualify if you...
- PVTT located in the portal vein branch opposite tumor, or presence of inferior vena cava tumor thrombus, extrahepatic metastasis, or invasion of adjacent organs
- Diagnosis of intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, fibrolamellar carcinoma, or active malignant tumors other than HCC within past 5 years except certain cured localized tumors
- Active or history of interstitial lung disease requiring steroids, active pneumonia, severe lung impairment, or active tuberculosis
- Active or history of autoimmune disease that may recur, except certain controlled conditions
- Use of immunosuppressive drugs or systemic corticosteroids (>10 mg/day prednisone) within 2 weeks before study
- Active infection, fever >38.5°C within 1 week before study, or recent therapeutic antibiotics use
- Congenital or acquired immunodeficiency (e.g., HIV)
- Receipt of live attenuated vaccines within 4 weeks before or during camrelizumab treatment period
- Significant bleeding disorders or tendencies within 6 months before study
- Known genetic or acquired bleeding or thrombotic disorders, or current therapeutic anticoagulant use
- Recent arterial thromboembolic events within 6 months
- Uncontrolled heart diseases including heart failure, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc interval
- Uncontrolled hypertension despite medication or history of hypertensive crisis
- Major vascular diseases requiring recent surgery or thrombosis
- Severe, unhealed wounds, ulcers, or untreated fractures
- Major surgery within 4 weeks before study
- Inability to swallow pills, malabsorption, or gastrointestinal obstruction within 6 months
- Use of strong CYP3A4/CYP2C19 inducers or inhibitors within 2 weeks before study
- Known allergy to monoclonal antibodies, antiangiogenic drugs, or excipients
- Participation in other drug clinical trials within 12 weeks before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
TREATMENT
Number of Arms
1
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