Status:
COMPLETED
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Hepatocellular Carcinoma
Radiotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12...
Eligibility Criteria
Inclusion
- Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
- Aged ≥18 years and \<80 years；
- ECOG 0-1;
- Live-GTV volume \> 700ml;
- BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
- Estimated life expectancy should be more than 3 months;
- Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months;
- Child-Pugh Score A5,A6,B7;
- Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal;
- ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
- Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
- Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
- Coagulation function: no bleeding tendency;
- Informed and voluntarily participated in the study and signed informed consent.
Exclusion
- Currently in the process of other clinical trials within recently four weeks;
- Previous abdominal radiotherapy and liver transplantation;
- Patients with severe chronic diseases of heart, kidney, liver and other important organs;
- Pregnant or lactating women;
- Suspected or indeed drug abusers, drug abusers and alcoholics;
- Allergic to lenvatinib or other treatments.
- Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04791176
Start Date
April 12 2021
End Date
May 23 2025
Last Update
August 14 2025
Active Locations (1)
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1
Bo Chen
Beijing, Beijing Municipality, China, 100021