Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

NCT04791176 | Completed Phase 2

• 1 other identifier: NCC2508
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatocellular Carcinoma; Radiotherapy; Lenvatinib

Keywords

hepatocellular carcinoma; intensity-modulated radiotherapy; portal vein thrombosis; lymph node metastasis; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• MST

  Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause

  24 months

Secondary Outcomes (3)

• ORR

  Assessment in 1 to 3 months after radiotherapy

• TTP

  24 months

• Rate of III-IV grade adverse events

  up to 24 months

Study Arms (1)

Lenvatinib and IMRT

EXPERIMENTAL

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

Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance

Interventions

concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance RADIATION

Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.

Lenvatinib and IMRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Bo Chen

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Lymphatic Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 10, 2021
• Study Start: April 12, 2021
• Primary Completion: June 30, 2024
• Study Completion: May 23, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)