Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC (NCT04791176) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
China64 participantsStarted 2021-04-12
Plain-language 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 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
MST
Timeframe: 24 months
Trial details
NCT IDNCT04791176
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences