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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Radiotherapy; Lenvatinib
• Intervention / Treatment: Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Bo Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lenvatinib and IMRT; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after the completion of radiotherapy.	Assessment in 1 to 3 months after radiotherapy
TTP	Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death	24 months
Rate of III-IV grade adverse events	Adverse events was evaluated during received protocol therapy according to CTCAE 4.03	up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; Lenvatinib; lymph node metastasis; portal vein thrombosis; intensity-modulated radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: NCC2508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No