EUCTR2018-000257-45-DE进行中（未招募）1 期
A phase Ib/II single-arm study evaluating the safety and efficacy ofcombined immunotherapy with mFOLFOX6, bevacizumab and atezolizumabin advanced-stage biliary cancer - COMBATBI
niversity Hospital Essen0 个研究点目标入组 35 人开始时间: 2021年3月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must fulfill all of the following criteria for study entry:
- •1. Signed informed consent form
- •2. Age = 18 years by the time of inclusion in the study
- •3. Ability to comply with the study protocol, in the investigator’s judgment
- •4. Histologically confirmed advanced BTC
- •5. Patient must have received at least one prior line of systemic therapy in advanced-stage BTC
- •6. Adjuvant or neoadjuvant chemotherapy is allowed, provided it is completed at least 6 months before start of study treatment.
- •7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix VI)
- •8. Life expectancy > 12 weeks
- •9. Measurable disease, according to RECIST v1.1. Lesions intended to be biopsied should not be defined as target lesions.
- •10. Tumor must be accessible for biopsies and patient willing to provide tissue from a newly obtained biopsy of a tumor lesion. In exceptional cases, if a pre-treatment biopsy is not deemed feasible by the investigator, archival biopsies can be used after Sponsor approval has been obtained, as long as they were collected no more than 6 months prior to enrollment.
- •11. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •? WBC = 2.5 x 109/L
- •? ANC = 1.5 x 109/L without granulocyte colony-stimulating factor support
- •? Platelet count = 100 x 109/L without transfusion
- •? Hemoglobin = 9 g/dL. Patients may be transfused to meet this criterion.
- •? Albumin = 2.5 g/dL
- •? Serum total bilirubin = 3 ULN; patients with known Gilbert’s disease may have a total bilirubin = 3.0 x ULN
- •? Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and PTT < 1.5 ULN . The use of full dose oral or parenteral anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least three weeks at the time of initiation of study treatment. Prophylactic use of anticoagulants is allowed.
- •? Amylase and lipase = 1.5 x ULN
- •? AST, ALT and ALP = 3 x ULN with the following exceptions:
- •o Patients with documented liver metastases: AST and/or ALT = 5 x ULN
- •o Patients with documented liver or bone metastases: ALP = 5 x ULN
- •? Serum creatinine = 1.5 ? ULN or Creatinine clearance = 30 mL/min (calculated using the Cockcroft-Gault formula)
- •12. For women of childbearing potential: Negative serum pregnancy test within 21 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of = 1% per year during the treatment period and for at least 180 days after the last study treatment.
- •? A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- •? Examples of contraceptive methods with a failure rate of = 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
- •? The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., cale
排除标准
- •1. Malignancies other than BTC within 3 years prior to C1D1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome
- •2. Patients with known microsatellite instability high (MSI-H) status. Patients with unknown MSI status are eligible and the MSI status will be analyzed retrospectively. Patients who are then determined to be MSI high will be allowed to continue the study treatment, but will be replaced by microsatellite-stable (MSS) or MSI-low tumors.
- •3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques must have been completed at least 4 weeks prior to initiation of study treatment.
- •4. Radiation therapy within 21 days prior to C1D1 and/or persistence of radiation-related adverse effects
- •5. Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past
- •6. Spinal cord compression not definitively treated with surgery and/or radiation
- •7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •8. Uncontrolled tumor pain.
- •9. Treatment with any investigational agent or approved therapy within 14 days or two investigational agent half-lives (whichever is longer) prior to C1D1
- •10. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-PD-1 and anti-PD-L1 or VEGF/VEGFR inhibitors
- •11. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-FU toxicity
- •12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •13. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any components of atezolizumab or bevacizumab formulations
- •14. Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or thrombolytic agents for therapeutic purposes
- •15. History of clinically significant cardiac or pulmonary dysfunction
- •16. History of idiopathic pulmonary fibrosis, organizing pneumonia
- •17. Major surgical procedure within 4 weeks prior to C1D1 or anticipation of need for a major surgical procedure during the course of the study
- •18. Evidence of tumor invading or abutting major blood vessels
- •19. Serious non-healing wound, active ulcer or untreated bone fracture
- •20. History of abdominal fistula or gastrointestinal perforation within 6 months prior to C1D1
- •21. History of hemoptysis (= ½ teaspoon of bright red blood per episode), or any other serious hemorrhage, or at risk of bleeding
- •22. INR > 1.5 and aPTT > 1.5 x ULN within 14 daysprior to C1D1 (excluding patients on prophylactic or therapeutic anticoagulation)
- •23. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
- •24. Proteinuria at screening as demonstrated by urine dipstick = 2+ or 24-hour proteinuria > 1.0 g
- •25. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.
- •26. Systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to C1D1.
- •27. Autoimmune conditions with exceptions
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