EUCTR2017-003040-20-FI进行中（未招募）1 期
A phase II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer immunotherapy guided by genomic profiling versus platinum-based chemotherapy in patients with cancer of unknown primary site who have recieved three cycles of platinum doublet chemotherapy
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 790
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
- •Age >=18 years
- •Histologically-confirmed unresectable poor-risk or unfavorable prognosis subset of CUP as defined by European Society for Medical Oncology 2015 clinical practice guidelines for CUP
- •At least one lesion that is measurable according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Availability of a tumor Formalin-fixed paraffin-embedded (FFPE) block <=4 months old at the start of creening that is expected to be sufficient and suitable (in quantity and quality) for generation of comprehensive genomic profile using Foundation medicine tissue biopsy assay at a central reference pathology laboratory
- •Availability of local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis. If the slides used for the local test confirming local CUP diagnosis are not available, an FFPE block must be submitted that is sufficient to allow for central confirmation of CUP diagnosis
- •No prior systemic therapy for the treatment of CUP
- •- Prior local intratumoral therapy may be accepted. If prior local intratumoral therapy, at least one of the measurable lesion(s) must have not benefited from local intratumoral therapy
- •ECOG performance status of 0 or 1
- •Life expectancy >=12 weeks
- •Eligible for platinum-based chemotherapy
- •Adequate hematologic and end-organ function
- •Agrees to use protocol defined methods of contraception
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •Squamous cell CUP
- •Patients with histology and immunohistology profiles (per 2015
- •ESMO guidelines) that are not adenocarcinoma
- •or poorly differentiated carcinoma / adenocarcinoma, i.e., non-epithelial
- •cancer, extragonadal germ-cell tumor, neuroendocrine tumors, sarcoma,
- •melanoma, mesothelioma, hematologic malignancies (list is not
- •limitative)
- •Patient with an immunohistochemistry profile that provides a
- •definitive clinical indication of a primary
- •cancer with a specific treatment
- •Patients who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor are also excluded. These are: Poorly differentiated carcinoma with midline
- •distribution, women with papillary adenocarcinoma of the peritoneal
- •cavity, women with adenocarcinoma involving only the axillary lymph
- •nodes, squamous cell carcinoma of the cervical lymph nodes, poorly
- •differentiated neuroendocrine tumors, men with blastic bone metastases
- •and elevated prostate-specific antigen, patients with a single, small,
- •potentially resectable tumor, colon cancer-type CUP (including patients
- •with a CK7 negative, CK20 positive, CDX-2 positive
- •immunohistochemistry profile), CK7 positive, CK20 negative and TTF-1
- •positive tumors in a context suggestive of lung adenocarcinoma or
- •thyroid cancer, IHC profile definitely indicative of breast cancer OR an
- •IHC profile indicative of breast cancer and either a history of breast
- •cancer or lymph nodes in the drainage areas of the breast, high-grade
- •serious carcinoma histology and elevated CA125 tumor marker and/or a
- •mass in the gynecological tract or any tumor mass or lymph node in the
- •abdominal cavity, IHC profile suggestive of renal cell carcinoma and
- •renal lesions, with a Bosniak classification higher than IIF, IHC profile
- •compatible with cholangiocarcinoma or pancreatobiliary and 1 or 2 liver
- •lesions without extrahepatic disease or with only pulmonary metastases
- •and/or lymph nodes in the drainage areas of the liver
- •Known presence of brain or spinal cord metastasis, as determined by
- •CT or magnetic resonance imaging evaluation during screening
- •History or known presence of leptomeningeal disease
- •Known clinically significant history of liver disease consistent with
- •Child-Pugh Class B or C, including active viral or other hepatitis, current
- •alcohol abuse, or cirrhosis
- •Human immunodeficiency virus infection
- •Positive for hepatitis C virus antibody at screening. If a patient has a
- •positive HCV antibody test at screening, an HCV RNA test must also be
- •performed. A patient will be excluded from the study only if the HCV
- •antibody and the HCV RNA test are positive. If the HCV antibody test is
- •positive, but the HCV RNA test is negative, the patient may enroll in the
- •Positive for hepatitis B surface antigen (HBsAg) at screening. If HBsAg
- •test is negative but the total hepatitis B core antibody test (HBcAb) is
- •positive, hepatitis B virus DNA must be performed and if the resulting
- •HBV DNA test is positive, the patient will be excluded from the study
- •Active tuberculosis at screening
- •Active infections requiring intravenous antibiotics
- •Significant cardiovascular disease within 3 months prior to initiation of
- •study treatment, unstable arrhythmia, or unstable angina
- 另有 2 项未显示
研究者
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