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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: HAIC of FOLFOX
* Drug: H101
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAIC plus H101<br>Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery | Procedure: HAIC of FOLFOX<br>* administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries<br>* Other names: Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin;Drug: H101<br>* Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC<br>* Other names: Recombinant Human Type-5 Adenovirus;|
| Active Comparator: HAIC<br>Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery | Procedure: HAIC of FOLFOX<br>* administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries<br>* Other names: Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin;Drug: Placebos<br>* Patients receive normal saline 10ml in each session of HAIC<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of adverse events | Postoperative adverse events were graded based on CTCAE v4.03 | 30 days | 
| Conversion rate to resection | Patients receive subsequent resection. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Hepatic artery infusion chemotherapy, Oxaliplatin, 5-fluorouracil and leucovorin, Recombinant Human Type-5 Adenovirus