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Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

Primary Purpose

Hepatocellular Carcinoma, Radiotherapy, Lenvatinib

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, intensity-modulated radiotherapy, portal vein thrombosis, lymph node metastasis, Lenvatinib

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
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.

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;
Allergic to lenvatinib or other treatments.
Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction

Sites / Locations

Bo Chen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenvatinib and IMRT

Arm Description

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

Outcomes

Primary Outcome Measures

MST

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

Secondary Outcome Measures

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.

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

Rate of III-IV grade adverse events

Adverse events was evaluated during received protocol therapy according to CTCAE 4.03

Full Information

NCT ID

NCT04791176

First Posted

March 6, 2021

Last Updated

August 8, 2023

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04791176

Brief Title

Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

Official Title

Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 21, 2020 (Actual)

Primary Completion Date

August 30, 2022 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 8 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Radiotherapy, Lenvatinib

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lenvatinib and IMRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance

Intervention Description

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.

Primary Outcome Measure Information:

Title

MST

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

ORR

Description

Time Frame

Assessment in 1 to 3 months after radiotherapy

Title

TTP

Description

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

Time Frame

24 months

Title

Rate of III-IV grade adverse events

Description

Adverse events was evaluated during received protocol therapy according to CTCAE 4.03

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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. 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; Allergic to lenvatinib or other treatments. Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction

Facility Information:

Facility Name

Bo Chen

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

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Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

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