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Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

Primary Purpose

Hepatocellular Carcinoma

Status

Withdrawn

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Lenvatinib

PD-1 antibody

TACE

TACE Drug Protocol

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, TACE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
Barcelona clinic liver cancer-stage B
Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)
Eastern Cooperative Oncology Group performance status of 0 to 1
No Cirrhosis or cirrhotic status of Child-Pugh class A only
Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
Known history of HIV
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Known central nervous system tumors including metastatic brain disease

Sites / Locations

Cancer Center Sun Yat-sen University
Guangzhou Twelfth People 's Hospita
Kaiping Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib Plus PD-1

TACE

Arm Description

Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Time to progression

Adverse Events

Progression free survival

Full Information

NCT ID

NCT03791918

First Posted

January 1, 2019

Last Updated

April 30, 2019

Sponsor

Sun Yat-sen University

Collaborators

Kaiping Central Hospital, Guangzhou No.12 People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03791918

Brief Title

Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

Official Title

Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Kaiping Central Hospital, Guangzhou No.12 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

Detailed Description

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with hepatocellular carcinoma staged BCLC A/B especially for those with tumor beyond up-to-seven criteria. Recently, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody in intermediate-stage HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with PD-1 antibody over TACE.

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, TACE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lenvatinib Plus PD-1

Arm Type

Experimental

Arm Description

Arm Title

TACE

Arm Type

Active Comparator

Arm Description

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

E7080, Lenvima

Intervention Description

12 mg (or 8 mg) once daily (QD) oral dosing.

Intervention Type

Drug

Intervention Name(s)

PD-1 antibody

Other Intervention Name(s)

Programmed cell death 1 antibody

Intervention Description

3mg/kg intravenously every 2 weeks

Intervention Type

Procedure

Intervention Name(s)

TACE

Other Intervention Name(s)

Transarterial chemoembolization

Intervention Description

A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.

Intervention Type

Drug

Intervention Name(s)

TACE Drug Protocol

Other Intervention Name(s)

Drugs for transarterial chemotherapy and embolization

Intervention Description

lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame

24 months

Title

Adverse Events

Time Frame

24 months

Title

Progression free survival

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. Barcelona clinic liver cancer-stage B Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors) Eastern Cooperative Oncology Group performance status of 0 to 1 No Cirrhosis or cirrhotic status of Child-Pugh class A only Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy. The following laboratory parameters: Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. Known central nervous system tumors including metastatic brain disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Guangzhou Twelfth People 's Hospita

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510620

Country

China

Facility Name

Kaiping Central Hospital

City

Kaiping

State/Province

Guangdong

ZIP/Postal Code

529300

Country

China

12. IPD Sharing Statement

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Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

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