KCT0003655招募中未知
Phase II study of avelumab in metastatic gastronetro-pancreatic (GEP) neuroendocrine carcinoma (NEC, WHO grade 3) as second-line treatment after failing to etoposide+cisplatin: integration of genomic analysis to identify predictive molecular subtypes
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Subjects with the intent and ability to provide written consent/approval for this clinical trial. The subjects may also provide consent for biomedical research. However, subjects may participate in state clinical trials without participating in biomedical studies.
- •2. Subjects over the age of 20 at the time of signing the consent form
- •3. Subjects whose diagnosis of the GEP-NEC has been verified organically or cytologically, including all gastrointestinal tract
- •4. Subjects with transitive diseases with biopsy areas (base and follow-up surveys) or patients with non-modifiable diseases of local progression
- •5. Subjects who experience the progression of proven objective radiological or clinical diseases during or after primary therapy containing any platinum/etoposide
- •a. In order to be considered secondary, the subject must have a record of the progression of the disease during primary care. The progression of the disease can be confirmed by CT scans or clinical evidence (such as cellular reports from new multiple or pleural extraction).
- •b. Where appropriate, new or deteriorated malignant omissions (recorded by ultrasound) may be identified by pathology standards (organics and/or cellularity).
- •c. Those who experience clinical disease progression during the final administration of secondary cancer therapy or within six months after final administration are eligible for registration if they have received platinum/etc.
- •d. In order to be suitable, the subject should have been given platinum/etoposide 2 regimen at least once. During primary treatment, dose reduction and discontinuation of one of these drugs, and conversion/extraction to a new drug are permitted; however, a record of disease progress is required during/after primary treatment. Thus, persons who stop responding abnormally before the progression of the disease during primary treatment are not appropriate until records confirm the progression of the disease.
- •6. Subjects with lesions that can be measured based on mRECIST according to the tester's assessment. Tumor lesions located in previously irradiated areas are considered measurable if progress is confirmed on these lesions.
- •a. NOTE: Exactly the same image acquisition and processing parameters should be used throughout the clinical trial.
- •7. Targets willing to provide fresh tissue based on the adequacy of tissue sample quality for biometric analysis and for biometric assessment. Repetitive samples may be required if appropriate tissue is not provided. They prefer newly acquired endoscopic biopsy samples rather than storage samples, and prefer formalin-fixed and paraffin-possession (FFPE) block samples to slides.
- •a. Newly obtained samples are defined as samples obtained up to six weeks (42 days) prior to commencement of treatment on the first day. The test subject may submit a sample for storage if it cannot provide a newly acquired sample (e.g. not accessible or safety concerns of the subject).
- •b. In addition, collection of storage tissue samples, even if newly acquired vs. storage samples, is required to support the evaluation of the clinical usability of biocompetitive assessment (if possible) would not be required for clinical purposes; however.
- •8. Subjects with status 0 or 1 on the ECOG performance scale.
- •9. Subjects whose long-term capability has been demonstrated as defined in Table 2. All screening clinical laboratory examinations are conducted within 10 days prior to commencement of treatment.
- •10. Female subjects of t
排除标准
- •1. Currently participating in clinical trials and receiving clinical trial therapy, or participating in a clinical trial within four weeks prior to the initial administration of clinical trial treatments, or using clinical testing devices.
- •2. Subjects with a 1 or 2 grade neuroendocrinosis tumor in the GI tube.
- •3. Subjects diagnosed with immunodeficiency or administered full-body steroids or other types of immunosuppression therapy within seven days prior to the initial administration of clinical trial treatments.
- •4. Subjects whose past history of active TB is known
- •5. Subjects who are overreacting to Avelumb or its sub-types.
- •6. Target recovery (i.e., = 1st grade) from adverse reactions caused by drugs administered within 4 weeks prior to clinical trial.
- •7. The patient is recovered from adverse reactions caused by prior chemotherapy, targeted micro-molecular therapy or radiotherapy within two weeks prior to the first day of clinical trial (i.e., = 1 or baseline).
- •- Note: = Test subjects with secondary neuropathy are exempt from this criterion and may be suitable for clinical trials.
- •- Note: If the test subjects had received algebraic treatment, they must have been properly recovered from toxicity and/or complications caused by such intervention before treatment could begin.
- •8. Persons tested for additional malignant tumors that are currently in progress or require active treatment. Exceptions include skin basal cell carcinoma or skin flat cell cancer or cervical cervical cervical endodermal cancer, which has been treated with potential full-treatment.
- •9. The active central nervous system (CNS) transfer and/or cancer meningitis are known to be tested. Test subjects with previously treated brain transitions are stable (if they are not used for at least four weeks prior to the initial administration of clinical trial treatments, there is no evidence of at least seven weeks of progress by video, and no evidence of new or extended brain transfer). Exceptions include cancerous meningitis, which excludes clinical stability.
- •10. Test subjects with active autoimmune disease who have treated the body in the past two years (i.e., using disease control agents, corticosteroid or immunosuppressant). Alternative therapies (e.g., physiological corticosteroid replacement therapy for Tiroxin, insulin or adrenal or pituitary failure) are not considered to be types of full-body care.
- •11. Clinically significant (i.e., active) cardiovascular disease/sickness (before registration < 6 months), myocardial infarction (before registration < 6 months), unstable heart disease, and depression in New York.
- •12. Past organ transplants, including homogenous hematopoietic stem cell transplants.
- •13. Test subjects with known or substantiated past history of epilepsy lung disease or active, non-inflammatory pneumonia.
- •14. Test subjects with active infections that require full body care.
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