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TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04954781
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 15, 2021
Information provided by (Responsible Party):
Peng Wang, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Drug: Tislelizumab Combination Product: TACE Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : July 15, 2024

Arm Intervention/treatment
Experimental: TACE in combination with Tislelizumab Drug: Tislelizumab
Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Combination Product: TACE
TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: max 24 months ]
    ORR according to RECIST 1.1 for advanced intrahepatic cholangiocarcinoma.

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: max 24 months ]
  2. Progression-Free Survival [ Time Frame: max 24 months ]
  3. Overall survival [ Time Frame: max 42 months ]
  4. Disease control rate [ Time Frame: max 24 months ]
  5. Adverse Events [ Time Frame: max 42 months ]
    Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. history of interstitial lung disease
    2. Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
    3. known acute or chronic pancreatitis
    4. active tuberculosis
    5. any other active infection (viral, fungal or bacterial) requiring systemic therapy
    6. history of allogeneic tissue/solid organ transplant
    7. 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.
    8. 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.
    9. Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.
    10. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04954781

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Contact: Peng Wang, MD 86-21-64175590

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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Peng Wang, Doctor    8621-64175590 ext 83630   
Principal Investigator: Peng Wang, Doctor         
Sponsors and Collaborators
Fudan University
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Principal Investigator: Peng Wang, MD Fudan University
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Responsible Party: Peng Wang, Professor, Fudan University Identifier: NCT04954781    
Other Study ID Numbers: MIT-010
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type