CTRI/2018/02/011808进行中(未招募)2 期
The assessment of potential benefits of molecular analysis and in vitro chemo response directed at opening treatment options for relapsed and refractory metastatic solid organ tumors. - RESILIeNT (The assessment of potential benefits of molecular analysis directed at opening treatment options for RElapsed and refractory metaStatIc SoLId OrgaN Tumors.)
Datar Cancer Genetics Limited0 个研究点目标入组 209 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 209
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age â?? 18 to 70 years (male or female);
- •2.Cancer of any solid organ, Sarcomas, Melanomas
- •3.Should have ECOG score of maximum 2;
- •4.Patient should have progressed on at least 3 SOC lines, if any, of therapy and have no further SOC option/ option is beyond financial reach (such as immunotherapy/ targeted therapy etc.). Three SOC lines would include surgery / RT / Cytotoxic therapy / targeted therapy;
- •5.Patient should be willing and fit for fresh tissue biopsy for obtaining live tumor cells / tapping of ascetic fluid / pleural fluid/ CSF etc. as the case may be;
- •6.The last failed SOC therapy should have resulted in a Progression Free Survival of <90 days;
- •7.Patient should be able and willing to undertake treatment as may be advised after the analysis by DCGL with good compliance history in the past;
- •8.Patient should be willing and ready for baseline PET Scan and/or CT and/or USG and/or MRI and follow-up scans (usually the first follow-up scan is after 30 days followed by further scans at 75 days and 120 days);
- •9.Patient is willing and can tolerate cytotoxic and targeted therapy (labelled / off-label / repurposed / natural tumor inhibiting supplements);
- •10.Female patient is not pregnant / lactating;
- •11.Provision of signed and dated informed consent form
- •12.Stated willingness to comply with all study procedures
- •13.Patients must have measurable disease on radiological imaging post biopsy to monitor treatment response
排除标准
- •1. Lymphomas, Leukemias, Myelomas.
- •2. Life threatening co-morbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepatic or Renal Function or any psychological deficits etc.
- •3. Not fulfilling inclusion criteria
研究者
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