TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    25
  • sponsor
    Fudan University
Updated on 21 July 2021
ct scan
renal function
neutrophil count
TACE

Summary

The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.

Description

Transarterial chemoembolization (TACE) is commonly used for the treatment of advanced liver cancer. Recent studies have suggested that TACE induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Therefore, this study aims to evaluate the efficacy and safety of TACE combined with anti-PD-1 antibody in patients in advanced intrahepatic cholangiocarcinoma.

Details
Condition Intrahepatic Bile Duct Carcinoma, Adenocarcinoma, Malignant Adenoma, Intrahepatic Cholangiocarcinoma
Treatment TACE, tislelizumab
Clinical Study IdentifierNCT04954781
SponsorFudan University
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent obtained
Age 18 years at the time of study entry
Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma
Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity
At least one measurable site of disease as defined by RECIST1.1 criteria with spiral CT scan or MRI
Performance status (PS) 2 (ECOG scale)
Life expectancy of at least 12 weeks
Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count 1,500/L, platelets 75 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

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
RFA 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
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 -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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