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

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: HAIC of FOLFOX; Drug: H101; Drug: Placebos

• Registration Number: NCT03780049
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAIC plus H101	HAIC of FOLFOX	Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
HAIC plus H101	H101	Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
HAIC	HAIC of FOLFOX	Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
HAIC	Placebos	Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	24 months	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.
Number of adverse events	30 days	Postoperative adverse events were graded based on CTCAE v4.03
Conversion rate to resection	24 months	Patients receive subsequent resection.

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China