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Clinical Trial for GALNT14 Genotype - Guided, Sorafenib in Combination With TACE in Hepatocellular Carcinoma

NCT02504983 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-05

No results posted yet for this study

Summary

Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect varies among studies conducted in different areas of the world. The objectives of this study are (1) to understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT genotype patients can benefit from TACE plus sorafenib (Nexavar) combination therapy. Patients enrolled will be stratified by GALNT14 genotyping. The GALNT14 "non-TT" patients were then randomized into two subgroups to evaluate the safety, tolerability and efficacy of TACE plus sorafenib therapy.

The primary endpoint of this study is the efficacy of TACE with or without sorafenib combination therapy evaluated by complete remission (CR).

The secondary endpoints are:

1. Time to partial or complete response (PR + CR).
2. Time-to-tumor-progression (TTP) and the progression free survival (PFS).
3. Overall survival (OS).
4. Safety and tolerability of TACE plus sorafenib therapy.

Conditions

Interventions

DRUG

sorafenib

sorafenib is an oral, multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma

PROCEDURE

TACE

Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chau-Ting Yeh, MD/PhD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
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 NCT02504983 on ClinicalTrials.gov