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Trial Title:
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
NCT ID:
NCT06389422
Condition:
Hepatocellular Carcinoma
Radiotherapy
Pembrolizumab
Tumor Thrombosis
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Pembrolizumab
Conditions: Keywords:
Hepatocellular Carcinoma
Radiotherapy
Pembrolizumab
Tumor Thrombosis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Moderate-dose Hypofractionated Intensity-modulated Radiotherapy
Description:
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.
Arm group label:
Radiotherapy and Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
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.
Arm group label:
Radiotherapy and Pembrolizumab
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Confirmed clinically or histopathologically as hepatocellular carcinoma,
concurrently with portal vein thrombosis or hepatic vein thrombosis;
2. Age 18-90 years;
3. Liver-GTV volume<700ml or the estimated volume of Liver-GTV receiving less than 5 Gy
of irradiation<300ml but the average dose of Liver-GTV needs to be <18Gy;
4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted
therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2
therapies;
5. ECOG performance status 0-2, expected survival greater than 1 month;
6. Allowing patients with distant metastases;
7. Child-Pugh A5, A6, B7 and B8;
8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper
limit; TBIL <60umol/L.
9. No significant abnormalities in the electrocardiogram, no apparent heart failure,
and no contraindications for anti-PD-1 treatment;
10. CRE, BUN within 2.5 times the normal upper limit;
11. Hb ≥ 50g/L, ANC ≥ 0.5 × 10^9 /L, PLT ≥ 30 × 10^9 /L; patients with a history of
gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment
with Hb ≥ 60g/L and a significant rising trend;
12. Patients voluntarily participate in this clinical trial and sign an informed consent
form.
Exclusion Criteria:
1. Currently participating in other clinical trials;
2. Previously received abdominal radiotherapy or liver transplantation;
3. Individuals with severe chronic disease conditions affecting vital organs such as
the heart, kidneys, or liver;
4. Severe ascites with noticeable symptoms, anticipated to be unrelieved after
treatment.
5. Suspected or confirmed drug addiction, medicine abuse,or alcoholism
6. Pregnant or lactating women;
7. Severe mental or neurological disorders
8. Presence of other life-threatening malignancy within the last 3 years before the
start of the study (excluding superficial skin cancer, localized low-grade malignant
tumor and in situ carcinoma).
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Chen, MD
Phone:
0086-13240000876
Email:
chenboo@outlook.com
Start date:
May 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389422
