TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    May 10, 2023
  • participants needed
    25
  • sponsor
    Fudan University
Updated on 16 June 2022
ct scan
renal function
international normalized ratio
antiviral therapy
neutrophil count
TACE
chemoembolization
antiviral drugs
sintilimab
transcatheter arterial chemoembolisation

Summary

The objective of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma as first line therapy.

Description

The transarterial chemoembolization (TACE) is commonly used for the treatment of advanced hepatocellular carcinoma. Early randomized trials suggested that TACE can be accepted as the standard treatment for advanced stage disease. However, outcome of patients treated with TACE in real-life cohorts is still very poor.

Recent studies have also supported a safe combination of immune checkpoint inhibition with TACE. Therefore, the objective of this study is to evaluate the efficacy and safety of TACE combined with anti-pd-1 antibody in patients in advanced hepatocellular carcinoma.

Details
Condition Hepatocellular Carcinoma
Treatment TACE, Sintilimab
Clinical Study IdentifierNCT04297280
SponsorFudan University
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent obtained
Age ≥ 18 years at time of study entry
Multinodular or large, solitary hepatocellular carcinoma, not eligible for resection or local ablation, Tumor burden below 50% of liver volume
Histologically confirmed diagnosis of hepatocellular carcinoma
At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI
Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale)
Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy
Life expectancy of at least 12 weeks
Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up

Exclusion Criteria

Diffuse hepatocellular carcinoma or presence of vascular invasion or extrahepatic spread with the following exceptions: Invasion of a segmental portal vein or hepatic veins; or limited extrahepatic metastases with one organ system manifestations
Patients on a liver transplantation list or with advanced liver disease
Total thrombosis or total invasion of the main branch of the portal vein
History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein
Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy
Prior treatment with TACE
Radiofrequency ablation and resection administered less then 4 weeks prior to study treatment start
Radiotherapy administered less then 4 weeks prior to study treatment start
Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery
Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix
Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV)
Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer
Previous treatment in the present study (does not include screening failure)
Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to
history of interstitial lung disease
Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
known acute or chronic pancreatitis
active tuberculosis
any other active infection (viral, fungal or bacterial) requiring systemic therapy
history of allogeneic tissue/solid organ transplant
diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study
Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment
History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS
Medication that is known to interfere with any of the agents applied in the trial
Any other efficacious cancer treatment except protocol specified treatment at study start
Patient has received any other investigational product within 28 days of study entry
Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
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