TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

Launched by FUDAN UNIVERSITY · Jul 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two treatments, TACE (transarterial chemoembolization) and Tislelizumab, for patients with advanced intrahepatic cholangiocarcinoma, a type of cancer that starts in the bile ducts inside the liver. The goal is to see how well this combination works and how safe it is for patients who have already tried one type of systemic therapy that did not work for them. The trial is currently looking for participants who are at least 18 years old and have a confirmed diagnosis of this cancer that cannot be surgically removed or has spread to other areas.

To join the study, participants must be in relatively good health, meaning they have a life expectancy of at least 12 weeks and meet certain blood and organ function requirements. They should also have had measurable disease progression after their first treatment. If eligible, participants can expect to receive the study treatment and undergo regular check-ups throughout the trial. It's important to note that there are some restrictions for potential participants, including certain medical conditions and recent treatments that could affect their ability to participate. Overall, this trial aims to explore a new treatment option for a challenging cancer, offering hope for improved outcomes.

Gender

ALL

Eligibility criteria

• 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.