MedTrace Logo

A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver

NCT05647954 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-12-13

No results posted yet for this study

Summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS) and Overall Survival(OS), achieved by HX008 Plus Transcatheter Arterial Chemoembolization (TACE) or Temozolomide Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver.

Conditions

  • Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms

Interventions

DRUG

HX008 + TACE

HX008 Subjects receive HX008 200 mg intravenous (IV) ,day1,every 3 weeks (Q3W) Procedure: TACE cisplatin 75 mg/sqm, day1, every 6 weeks; fotemustine 100 mg/sqm, day2, every 6 weeks; lipiodol is usually 5-10 ml (According to the location and number of lesions).

DRUG

Temozolomide + TACE

Temozolomide Subjects receive Temozolomide 200 mg/sqm intravenous (IV),day1-5, every 3 weeks (Q3W) Procedure: TACE : cisplatin 75 mg/sqm, day1, every 6 weeks; fotemustine 100 mg/sqm, day2, every 6 weeks; lipiodol is usually 5-10 ml (According to the location and number of lesions).

DRUG

Pembrolizumab

Subjects receive Pembrolizumab 2 mg/kg intravenous (IV),day1, every 3 weeks (Q3W)

Sponsors & Collaborators

  • Taizhou Hanzhong biomedical co. LTD

    lead INDUSTRY

Principal Investigators

  • Jun Guo, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-12-30
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05647954 on ClinicalTrials.gov