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Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)

NCT03510871 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-07-08

No results posted yet for this study

Summary

Objectives:

1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC;
2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment;
3. To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

nivolumab, ipilimumab

All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles).

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • Tri-Service General Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Tsang-Wu Liu, MD, PhD · Taiwan Cooperative Oncology Group, NHRI

  • Chiun Hsu, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Taiwan

Study Locations

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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 NCT03510871 on ClinicalTrials.gov