問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberD4190C00022
NCT Number(ClinicalTrials.gov Identfier)NCT02519348

2015-09-10 - 2023-12-31

Phase II

Recruiting3

ICD-10C22.9

Malignant neoplasm of liver, not specified as primary or secondary

A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chen-Chun Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Unresectable Hepatocellular Carcinoma

Objectives

To assess the safety and tolerability of MEDI4736 and tremelimumab administered as monotherapy and in combination to subjects with unresectable HCC.

Test Drug

MEDI4736 / Tremelimumab

Active Ingredient

MEDI4736
Tremelimumab

Dosage Form

500 mg/vial
400 mg/vial

Dosage

50 mg/mL
20 mg/mL

Endpoints

Adverse events (AEs), serious adverse events (SAEs), discontinuation of investigational product(s) due to toxicity, and changes from baseline in laboratory parameters (including liver and viral laboratory tests), electrocardiograms (ECG), and vital signs.

Inclution Criteria

Inclusion Criteria:
1. Male or female subjects
2. 18 years and older (Japan-20 years and older)
3. Confirmed HCC based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
4. Immunotherapy-naïve
5. Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.

Exclusion Criteria

Exclusion Criteria:
1. Prior exposure to immune-mediated therapy
2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
3. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
4. Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
5. Main portal vein thrombosis (Vp4) as documented on imaging
6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
7. Active or prior documented autoimmune or inflammatory disease with some exceptions
8. Current or prior use of immunosuppressive medication within 14 days with some exceptions

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    129 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB