Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Radiotherapy; Hepatocellular Carcinoma; Lenvatinib

Treatments: Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT04791176

NCC2508

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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；
2. Aged ≥18 years and <80 years；
3. ECOG 0-1;
4. Live-GTV volume > 700ml;
5. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
6. Estimated life expectancy should be more than 3 months;
7. 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;
8. Child-Pugh Score A5,A6,B7;
9. 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;
10. ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
11. Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
12. Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
13. Coagulation function: no bleeding tendency;
14. Informed and voluntarily participated in the study and signed informed consent.

Exclusion criteria

1. Currently in the process of other clinical trials within recently four weeks;
2. Previous abdominal radiotherapy and liver transplantation;
3. Patients with severe chronic diseases of heart, kidney, liver and other important organs;
4. Pregnant or lactating women;
5. Suspected or indeed drug abusers, drug abusers and alcoholics;
6. Allergic to lenvatinib or other treatments.
7. Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Lenvatinib and IMRT

Experimental group

Description:

Concurrent Lenvatinib and IMRT, followed Lenvatinib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved

Treatment:

Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance