Actively Recruiting
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-04-29
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
CONDITIONS
Official 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 or hepatic vein thrombosis
- Age between 18 and 90 years
- Liver-GTV volume less than 700 ml or estimated liver-GTV volume receiving less than 5 Gy irradiation less than 300 ml with an average dose below 18 Gy
- Previous treatments allowed except immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies
- ECOG performance status of 0 to 2 with expected survival longer than 1 month
- Patients with distant metastases are allowed
- Child-Pugh classifications A5, A6, B7, and B8
- ALT and AST within 2.5 times the normal upper limit; total bilirubin less than 60 umol/L
- No significant electrocardiogram abnormalities or heart failure; no contraindications for anti-PD-1 treatment
- Creatinine and blood urea nitrogen within 2.5 times the normal upper limit
- Hemoglobin at least 50 g/L, absolute neutrophil count at least 0.5 x 10^9/L, platelet count at least 30 x 10^9/L; controlled gastrointestinal bleeding for over 2 weeks before enrollment with hemoglobin at least 60 g/L and significant rising trend
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Currently enrolled in other clinical trials
- Previous abdominal radiotherapy or liver transplantation
- Severe chronic diseases affecting vital organs such as heart, kidneys, or liver
- Severe symptomatic ascites unlikely to improve after treatment
- Suspected or confirmed drug addiction, medicine abuse, or alcoholism
- Pregnant or lactating women
- Severe mental or neurological disorders
- Diagnosis of other life-threatening malignancy within 3 years before study start (excluding superficial skin cancer, localized low-grade malignancy, or in situ carcinoma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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