HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

Carcinoma, Hepatocellular Clinical Trial

Official title:

HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618367
• Other study ID #: GYEYJR-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

4. 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.

9. 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Portal Vein Tumor Thrombus
• Sintilimab
• Thrombosis

Intervention

Procedure:
• Hepatic arterial infusion chemotherapy
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• Sintilimab
200mg intravenously every 3weeks

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival rate at 6 months	Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause	6 months
Secondary	Overall survival (OS)	OS is the length of time from the date of randomization until death from any cause.	6 months
Secondary	Progression free survival (PFS)	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.	6 months
Secondary	Objective response rate (ORR)	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.	6 months
Secondary	Adverse events	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.	6 months