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临床试验/CTRI/2018/02/011808
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

发起方
Datar Cancer Genetics Limited

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