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HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

Primary Purpose

Carcinoma, Hepatocellular, Liver Neoplasms, Sintilimab

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hepatic arterial infusion chemotherapy

Lenvatinib

Sintilimab

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Carcinoma, Hepatocellular, lenvatinib, Sintilimab, portal vein tumor thrombus, oxaliplatin, 5-fluorouracil, leucovorin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAIC plus Lenvatinib and Sintilimab

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)

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

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.

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.

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.

Full Information

NCT ID

NCT04618367

First Posted

October 31, 2020

Last Updated

December 20, 2020

Sponsor

Sun Yat-sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04618367

Brief Title

HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Carcinoma, Hepatocellular, lenvatinib, Sintilimab, portal vein tumor thrombus, oxaliplatin, 5-fluorouracil, leucovorin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HAIC plus Lenvatinib and Sintilimab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Hepatic arterial infusion chemotherapy

Intervention Description

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

TKI inhibits

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

programmed cell death protein-1 (PD-1) antibody

Intervention Description

200mg intravenously every 3 weeks

Primary Outcome Measure Information:

Title

Progression free survival rate at 6 months

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

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

Time Frame

6 months

Title

Progression free survival (PFS)

Description

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.

Time Frame

6 months

Title

Objective response rate (ORR)

Description

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.

Time Frame

6 months

Title

Adverse events

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qunfnag Zhou, MD

Phone

86 19868000115

zhouqun988509@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kangshun Zhu, MD

Organizational Affiliation

Second Affiliated Hospital of Guangzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Second Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qunfang Zhou, MD

Phone

86 19868000115

zhouqun988509@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

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