HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

Not Applicable

Completed

• Conditions: Carcinoma, Hepatocellular; Liver Neoplasms; Sintilimab; Portal Vein Tumor Thrombus
• Interventions: Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Sintilimab

• Registration Number: NCT04618367
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

Detailed Description

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 Sintilimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Study Timeline

• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-05
• Study Start: 2021-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. clinical diagnosis of HCC; 2. age between18 and 75 years; 3. refused to sorafenib treatment; 4. type I PVTT, type II PVTT, or type III PVTT. 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. 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 8. Prothrombin time ≤18s or international normalized ratio < 1.7. 9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria

• 1. Diffuse HCC; 2. Extrahepatic metastasis; 3. Obstructive PVTT involving both the left and right portal vein or main portal vein.

  2. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.

  3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAIC plus Lenvatinib and Sintilimab	Hepatic arterial infusion chemotherapy	Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 200 mg intravenously every 3 weeks.
HAIC plus Lenvatinib and Sintilimab	Lenvatinib	Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 200 mg intravenously every 3 weeks.
HAIC plus Lenvatinib and Sintilimab	Sintilimab	Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 200 mg intravenously every 3 weeks.

Primary Outcome Measures

Name	Time	Method
Progression free survival rate at 6 months	6 months	Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	6 months	OS is the length of time from the date of randomization until death from any cause.
Progression free survival (PFS)	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.
Objective response rate (ORR)	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.
Adverse events	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.

Trial Locations

Locations (1)

Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China