NCT04791176CompletedPhase 2
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 6 Mar 2021
- Start date
- 12 Apr 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04791176
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 64
- From 12 Apr 2021 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal radiotherapy and liver transplantation;
- Suspected or indeed drug abusers, drug abusers and alcoholics;
Other illness
- Patients with severe chronic diseases of heart, kidney, liver and other important organs;
- Allergic to lenvatinib or other treatments.
- Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
Other
- Currently in the process of other clinical trials within recently four weeks;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bo Chen Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.