HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

Hepatocellular Carcinoma Clinical Trial

Official title:

HAIC Synchronously Combined With Bevacizumab and Toripalimab First-line for Advanced Hepatocellular Carcinama

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04627363
• Other study ID #: GYEYJR-3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2020
• Source: Sun Yat-sen University
• Contact: Qunfnag Zhou, MD
• Phone: 86 19868000115
• Email: zhouqun988509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Description:

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, 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 Bevacizumab and Toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;

2. age between 18 and 75 years;

3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.

4. No previous use of any systemic therapy or recurrent HCC.

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. Cholangiocellular carcinoma (ICC);

2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;

3. Accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary HCC, ablation or system therapy as first line therapy for recurrent HCC.

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

• Bevacizumab
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms
• Oxaliplatin
• Toripalimab

Intervention

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

Drug:
• Bevacizumab
15mg/kg intravenously every 3 weeks
• Toripalimab
240mg intravenously every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

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