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

NCT03780049 | Unknown Phase 3 DMC

• 1 other identifier: HCC-S032
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic artery infusion chemotherapy; Oxaliplatin, 5-fluorouracil and leucovorin; Recombinant Human Type-5 Adenovirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  24 months

• Number of adverse events

  30 days

• Conversion rate to resection

  24 months

Study Arms (2)

HAIC plus H101

EXPERIMENTAL

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

Procedure: HAIC of FOLFOX; Drug: H101

HAIC

ACTIVE COMPARATOR

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

Procedure: HAIC of FOLFOX; Drug: Placebos

Interventions

HAIC of FOLFOX PROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Also known as: Hepatic artery infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin

HAIC; HAIC plus H101

H101 DRUG

Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC

Also known as: Recombinant Human Type-5 Adenovirus

HAIC plus H101

Placebos DRUG

Patients receive normal saline 10ml in each session of HAIC

Also known as: normal saline

HAIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil; Leucovorin; Saline Solution

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ming Shi, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, MD

CONTACT

+862087343938; shiming@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

CN (1)