Actively Recruiting
Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Pembrolizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-04-29
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of moderate-dose hypofractionated intensity-modulated radiotherapy and Pembrolizumab in patients with hepatocellular carcinoma that involves diffuse tumor thrombosis in both liver lobes. This Phase II, single-center, open-label study focuses on patients with specific liver tumor volume limits and aims to measure median overall survival as the primary outcome, along with response rates, progression-free survival, and treatment toxicity. Participants receive radiotherapy targeting all tumor lesions with a gross tumor dose of 25Gy over 5 fractions, with a maximum dose of 35Gy at the tumor center. Pembrolizumab is given concurrently at 200mg one week before or during radiotherapy, then continued intravenously every three weeks. Maintenance therapy with Lenvatinib 4mg alongside Pembrolizumab may be provided if suitable, continuing until disease progression or intolerance. Follow-up examinations are scheduled between one and three months after radiotherapy. During the study, participants undergo regular assessments including clinical examinations and monitoring for tumor response and side effects. Key outcomes tracked include overall survival over 24 months, objective response rate within 1 to 3 months post-radiotherapy, progression-free survival, and toxicity up to 24 months. The study involves treatment administration, follow-up visits, and ongoing evaluation to understand how patients respond to this combined therapy approach.
CONDITIONS
Brief Title
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed hepatocellular carcinoma with portal vein thrombosis or hepatic vein thrombosis
- Age between 18 and 90 years
- Liver-GTV volume less than 700ml or estimated liver-GTV receiving less than 5 Gy irradiation less than 300ml with average dose below 18Gy
- Previous treatments allowed except immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies
- ECOG performance status 0-2 with expected survival over 1 month
- Patients with distant metastases allowed
- Child-Pugh scores A5, A6, B7, or B8
- ALT and AST within 2.5 times normal upper limit; total bilirubin below 60umol/L
- No significant ECG abnormalities, no apparent heart failure, and no contraindications to anti-PD-1 treatment
- Creatinine and BUN within 2.5 times normal upper limit
- Hemoglobin ≥ 50g/L, ANC ≥ 0.5 x 10^9/L, platelets ≥ 30 x 10^9/L; controlled gastrointestinal bleeding for over 2 weeks with hemoglobin ≥ 60g/L and improving trend
- Voluntary participation with signed informed consent
You will not qualify if you...
- Currently participating in other clinical trials
- Previous abdominal radiotherapy or liver transplantation
- Severe chronic diseases affecting heart, kidneys, or liver
- Severe symptomatic ascites unlikely to improve with treatment
- Suspected or confirmed drug addiction, medicine abuse, or alcoholism
- Pregnant or breastfeeding women
- Severe mental or neurological disorders
- Other life-threatening cancers within the last 3 years, excluding certain skin and localized tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiotherapy over 5 fractions plus ongoing Pembrolizumab maintenance until progression or intolerance
Participants receive moderate-dose hypofractionated intensity-modulated radiotherapy concurrent with Pembrolizumab. Pembrolizumab is given intravenously every 3 weeks. Maintenance therapy with Pembrolizumab, with or without Lenvatinib, continues until disease progression or intolerance.
Weekly visits during radiotherapy and every 3 weeks for Pembrolizumab infusions
Duration - 1 to 3 months post-radiotherapy and up to 24 months for ongoing monitoring
Participants return for follow-up examinations to assess treatment response and monitor for toxicity.
Follow-up visits at 1 to 3 months after radiotherapy and periodic visits up to 24 months
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here