FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

NCT06201065 | Recruiting Phase 3 DMC

• 1 other identifier: SA23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; Lenvatinib; Oxaliplatin, Fluorouracil and Leucovorin; Hepatic arterial infusion chemotherapy; Toripalimab

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

  18 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  18 months

• Objective Response Rate (ORR)

  18 months

• Adverse Events

  30 days

Study Arms (2)

Experimental arm

EXPERIMENTAL

Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab

Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Toripalimab; Drug: oxaliplatin , fluorouracil, and leucovorin

Control arm

ACTIVE COMPARATOR

Hepatic arterial infusion chemotherapy plus lenvatinib

Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: oxaliplatin , fluorouracil, and leucovorin

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Control arm; Experimental arm

Lenvatinib DRUG

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

Control arm; Experimental arm

Toripalimab DRUG

240 mg iv.drip Q3W

Experimental arm

oxaliplatin , fluorouracil, and leucovorin DRUG

FOLFOX-HAIC

Control arm; Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 C
• Eastern Cooperative Oncology Group performance status of 0 to 2
• With no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• This study did not limit HBV DNA load. High HBV-DNA load was aollowed, but hepatitis-B patient must receive concurrent antiviral therapy.
• The following laboratory parameters:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib; toripalimab; Oxaliplatin; Fluorouracil; Leucovorin

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 11, 2024
• Study Start: December 26, 2023
• Primary Completion: July 26, 2025
• Study Completion (Estimated): December 26, 2026
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (1)