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

NCT03780049 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2020-05-21

No results posted yet for this study

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

Interventions

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

DRUG

Placebos

Patients receive normal saline 10ml in each session of HAIC

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Shi, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780049 on ClinicalTrials.gov