Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

NCT04627012 | Completed DMC

• 1 other identifier: GYEYJR-2
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.

Conditions

Hepatocellular Carcinoma; Anti-PD1 Antibody; Liver Diseases

Keywords

Tislelizumab; Lenvatinib; Toripalimab; Sintilimab; Camrelizumab; Keytruda; Opdivo

Outcome Measures

Primary Outcomes (2)

• Progression-Free-Survival(PFS)

  Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause

  24 months

• Overall survival (OS)

  OS is the length of time from the date of randomization until death from any cause.

  24 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  6 months

• Disease control rate(DCR)

  24 months

• Adverse events

  24 months

Interventions

Lenvatinib DRUG

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

Opdivo DRUG

3mg/mg intravenously every 3 weeks

Camrelizumab DRUG

200mg intravenously every 3 weeks

Keytruda DRUG

200mg intravenously every 3 weeks

Toripalimab DRUG

240mg intravenously every 3 weeks

Sintilimab DRUG

200mg intravenously every 3 weeks

Tislelizumab DRUG

200mg intravenously every 3 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.

You may qualify if:

• HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
• age between 18 and 75 years;
• Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
• Previous use of any systemic therapy but intolerant, impotent or drug resistant.
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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
• Prothrombin time ≤18s or international normalized ratio \< 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

• Cholangiocellular carcinoma (ICC);
• Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
• The survival or patients less than 3 months.
• Serious medical comorbidities.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Diseases

Interventions

lenvatinib; Nivolumab; camrelizumab; pembrolizumab; toripalimab; sintilimab; tislelizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: January 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: July 1, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)