EUCTR2017-001538-25-DE进行中（未招募）1 期
A randomized phase II trial of durvalumab and tremelimumab with gemcitabine or gemcitabine and cisplatin compared to gemcitabine and cisplatin in treatment-naïve patients with cholangio- and gallbladder carcinoma (IMMUCHEC) - IMMUCHEC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •1. Fully-informed written consent and locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •2. Age = 18 years.
- •3. Histologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma and available tumor tissue (block or at least 4 slides) for translational research.
- •4. Performance status (PS) = 1(ECOG scale).
- •5. At least one measurable site of disease as defined by RECISTv1.1 criteria.
- •6. Adequate bone marrow and renal function including the following: Hemoglobin = 9.0 g/dL; absolute neutrophil count = 1.5 x 10^9/L; platelets =100x 10^9 /L; Creatinine = 1.5 x upper normal limit.
- •7. Calculated creatinine clearance =40 mL/min as determined by the Cockcroft-Gault equation (using actual body weight)
- •Males: Creatinine CL (mL/min) = (Weight (kg) × (140 - Age)) / (72 × serum creatinine (mg/dL))
- •Females: Creatinine CL (mL/min) = (Weight (kg) × (140 - Age) × 0.85) / (72 × serum creatinine (mg/dL))
- •8. Adequate hepatic function (with stenting for any obstruction, if required) including the following: Total bilirubin = 2x upper normal limit; AST (SGOT), ALT (SGPT) = 5 x upper normal limit; prothrombin time = 60%; albumin = 30 g/L.
- •9. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- •10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •11. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study
- •2. Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
- •3. Prior immunotherapy or use of other investigational agents, including prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T-lymphocyte associated antigen-4 (anti-CTLA-4) antibody, therapeutic cancer vaccines.
- •4. Prior chemotherapy with gemcitabine, cisplatin and/or capecitabine (exception: gemcitabine, cisplatin and/or capecitabine in the adjuvant setting, last infusion has to be = 6 months prior randomization).
- •5. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •6. Any concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions for palliative intent is acceptable (eg, local radiotherapy).
- •7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drugs.
- •8. Major surgery (as defined by the Investigator) within 4 weeks prior to the first dose of the investigational product (IMP) of starting the study and patients must have recovered from effects of major surgery. Note: Local non-major surgery for palliative intent (eg, surgery of isolated lesions, per-cutaneous biliary drainage or biliary stenting) is acceptable.
- •9. History of allogenic organ transplantation.
- •10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
- •13. History of leptomeningeal carcinomatosis
- •14. Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a CT/ MRI of the brain prior to study entry.
- •15. History of active primary immunodeficiency
- •16. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg) result], hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •17. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
- •18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IMP and up to 30 days after the last dose of IMP.
- •19. Body weight =30 kg.
- •20. Female patients who
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