CTRI/2018/05/014178进行中（未招募）2 期
A two arm randomized open label prospective parallel design superiority Phase II clinical trial to evaluate the efficacy of a therapy administered based on guidance obtained from integrative molecular and in-vitro chemosensitivity analysis provided by the DCGL investigation platform (ExactaTM) versus standard of care therapy in newly diagnosed therapy naïve advanced/unresectable gallbladder cancer, cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer and glioblastoma. - ACTPrO
Datar Cancer Genetics Limited0 个研究点目标入组 0 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
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.Newly diagnosed therapy naïve advanced/unresectable gallbladder cancer, cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer and glioblastoma
- •3.Should have ECOG score of maximum 1;
- •4.Patient should be willing and fit for fresh tissue biopsy for obtaining live tumor cells / tapping of ascitic fluid / pleural fluid etc. as the case may be;
- •5.Patient should be financially able to undertake treatment as may be advised after the analysis by DCGL or SOC with good compliance history in the past;
- •6.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);
- •7.Patient is willing and can tolerate cytotoxic and targeted therapy (labelled / off-label / repurposed / natural tumor inhibiting supplements);
- •8.Female patient is not pregnant / lactating;
- •9.Provision of signed and dated informed consent form
- •10.Stated willingness to comply with all study procedures
- •11.Patients must have measurable disease on radiological imaging post biopsy to monitor treatment response
- •12.Patient does not have any contraindications to receive chemotherapy
- •13. Adequate organ function
- •Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
- •Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L
- •Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.
排除标准
- •1.Patients who fail to meet all of the above criteria will be excluded. Failing to meet any single criteria would be sufficient grounds for exclusion.
- •2.Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections, HIV, HPV, HBV, HCV, Tuberculosis etc.
- •3.Patients with active second malignancies
研究者
相似试验
招募中
2 期
The purpose of this study is to find out benefit of two drug chemotherapy versus one drug chemotherapy in Gall bladder cancerCTRI/2017/10/010112Tata Memorial Hospital
尚未招募
3 期
A study to assess the Patient navigation and symptom reporting with patient reported outcome in lung cancer patient.CTRI/2020/02/023511Tata Memorial Hospital
尚未招募
2 期
A clinical trail of Siddha drug MV Kashayam in Denguepositive patientsCTRI/2024/08/072099Gayathri
已完成
2 期
Clinical study to evaluate efficacy and safety in health & immunity related parameters of Dabur Ratnaprash formulatioCTRI/2014/07/004804Dabur India Ltd100
已完成
4 期
Clinical study to evaluate effectiveness, safety and tolerability of Dhathri Hair Care Cream in comparison with Regular Hair Cream in the management of hairfall and dandruff of the scalp.CTRI/2013/05/003644Dhathri Ayurveda Private Limited36