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Completed

NCT Number: NCT04044313

HAIC Plus Lenvatinib and Toripalimab for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated 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 HAIC plus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • The following laboratory parameters:

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

  • 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

Treatment and study plan

Hepatic Arterial Infusion Chemotherapy

Procedure

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Lenvatinib

Drug

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

Toripalimab

Drug

240mg intravenously every 3 weeks

Primary outcomes

  1. Progression free survival rate at 6 months

    Time frame: 6 months

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

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 6 months

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

  2. Progression free survival (PFS)

    Time frame: 6 months

    PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.

  3. Objective response rate (ORR)

    Time frame: 6 months

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.

  4. Adverse events

    Time frame: 6 months

    Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Sponsors and collaborators

Lead sponsor

Shi Ming

Other

Registry information

Official study title

Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Toripalimab for Advanced Hepatocellular Carcinoma： a Prospective, Single-arm Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 5, 2019
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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