HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Hepatocellular Carcinoma Clinical Trial

Official title:

Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03780049
• Other study ID #: HCC-S032
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: Ming Shi, MD
• Phone: +862087343938
• Email: shiming[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of HCC

• Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.

• With no previous treatment

• Single lesion with tumor size larger 7cm or multiple lesions

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

• BCLC A-B stage

• The following laboratory parameters:

Platelet count = 50,000/µL Hemoglobin = 8.5 g/dL Total bilirubin = 30mmol/L Serum albumin = 32 g/L ASL and AST = 6 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

Exclusion Criteria:

• Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (> grade 2 National Cancer Institute [NCI] -common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or other serious associated diseases will not be able to tolerate treatment

• With other malignant tumors

• Known or suspected allergy to the investigational agents or any agent given in association with this trial

• History of organ allograft

• Pregnant or lactating woman

• patients with poor compliance

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Drug:
• H101
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
• Placebos
Patients receive normal saline 10ml in each session of HAIC

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.	24 months
Secondary	Progression free survival (PFS)	PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.	24 months
Secondary	Number of adverse events	Postoperative adverse events were graded based on CTCAE v4.03	30 days
Secondary	Conversion rate to resection	Patients receive subsequent resection.	24 months