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Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)

NCT03893695 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-09

No results posted yet for this study

Summary

This single arm, open label, two stage study will be conducted in several medical centers around Taiwan. Stage one determine safety and tolerability in patients with HCC, and stage two assess anti-tumor activities of GT90001 in combination with nivolumab in patients with metastatic HCC. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study.

Conditions

  • Metastatic Hepatocellular Carcinoma
  • HCC
  • Combinations of Drugs; Dependence

Interventions

DRUG

GT90001 and Nivolumab

Stage1:Dose de-escalation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Sponsors & Collaborators

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Principal Investigators

  • Yuwei Xu · Suzhou Kintor Pharmaceuticals,inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-25
Primary Completion
2022-05-26
Completion
2022-09-27

Countries

  • Taiwan

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 NCT03893695 on ClinicalTrials.gov