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Clinical Trials List

Protocol NumberT2217
NCT Number(ClinicalTrials.gov Identfier)NCT03510871

2018-09-01 - 2022-12-31

Phase II

Recruiting8

ICD-10C22

Malignant neoplasm of liver and intrahepatic bile ducts

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

  • Trial Applicant

    National Health Research Institutes

  • Sponsor

    National Health Research Institutes

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator San-Chi Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Chen Lee Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Long-Bin Jeng 院長室
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yan-Shen Shan Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 林俊昌 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
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 何景良 Division of General Internal Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Long-Bin Jeng 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Chiun Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Hepatocellular Carcinoma (HCC)

Objectives

Objectives: 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; To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment; To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.

Test Drug

nivolumab﹝Opdivo﹞/ ipilimumab ﹝Yervoy﹞

Active Ingredient

nivolumab ；ipilimumab

Dosage Form

injection

Dosage

100mg/ 10mL/ vial；200 mg/ 40 mL/ vial

Endpoints

Primary objective:
• To evaluate the percentage of subjects whose tumor(s) may shrink for > 10% (the sum of the diameters of the target lesions according to RECIST 1.1) after nivolumab + ipilimumab treatment.
Secondary objectives:
• To demonstrate the objective response rate (per RECIST 1.1) of nivolumab + ipilimumab in patients with HCC who have potential for curative surgery.
• To evaluate the proportion of patients with HCC whose tumors can be down-staged (according to AJCC) by neoadjuvant nivolumab + ipilimumab.
• To evaluate the progression-free survival of patients who receive neoadjuvant nivolumab + ipilimumab followed by surgery.
• To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment.
• To collect HCC tumor tissue, peripheral blood, and stool samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.

Inclution Criteria

Inclusion criteria:
 Histological diagnosis of HCC with potential for curative surgical resection fulfilling one of the following criteria:
 Tumor(s) with macrovascular invasion.
 Tumors with one of the following features:
 multiple tumors and bilateral lobes involvement, none more than 5 cm
 tumor number > 3, none more than 5 cm
 multiple tumors none more than 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL)
 solitary tumor > 5 cm, with significant portal hypertension (splenomegaly, esophageal varices or platelet < 100,000/μL)
 No evidence of extra-hepatic metastases.
 At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
 Prior percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy are allowed if aforementioned local therapy is given at least 4 weeks prior to enrollment and progressive or recurrent disease is documented.
 Age  20 years old.
 ECOG performance status 0 or 1.
 Child-Pugh class A liver function.
 White blood count  2,000/L (stable, off any growth factor within 4 weeks of study drug administration) ; platelet count  60,000/L.
 Liver transaminases (ALT and AST)  5 times upper limit of normal values (ULN); total bilirubin  1.5 times ULN; serum creatinine  1.5 times ULN; creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault formula).
 Subjects with chronic hepatitis B virus infection (HBV surface antigen (HBsAg) positive) must start antiviral therapy with nucleoside analogs (e.g., entecavir or tenofovir, according to current practice guidelines) before start of study drug treatment.

Exclusion Criteria

Exclusion criteria:
 Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, systemic therapy, or other experimental therapy
 Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, or transarterial embolization administered within 4 weeks prior to enrollment.
 Major surgical procedure within 2 weeks or minor surgical procedure within 1 week prior to enrollment.
 History of esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
 History of upper gastrointestinal bleeding within 1 year.
 Known human immunodeficiency virus (HIV) infection
 Major systemic diseases that the investigator considers inappropriate for participation.
 History of other malignancies except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
 Any active autoimmune disease or history of known autoimmune disease except for vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
 Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
 Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
 Requirement of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
 Prior organ allograft or allogeneic bone marrow transplantation.
 Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    50 participants

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