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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: H101; Procedure: HAIC of FOLFOX; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03780049

HCC-S032

Details and patient eligibility

About

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.

Enrollment: 304 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 2 patient groups

HAIC plus H101

Experimental group

Description:

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery

Treatment:

Procedure: HAIC of FOLFOX

Drug: H101

HAIC

Active Comparator group

Description:

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery

Treatment:

Drug: Placebos

Procedure: HAIC of FOLFOX