Health Condition 1: C00-D49- Neoplasms Health Condition 2: null- Newly diagnosed therapy naïve advanced/unresectable gallbladder cancer, cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer and glioblastoma patients
Conditions
Interventions
Intervention1: Available drugs will be
individualized as per in vitro and molecular analysis
reports:
This trial is not for any new drug or molecule. In this trial chemotherapy and nonchemotherapy dr
Sponsors
Datar Cancer Genetics Limited
Canconnect Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 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 = 30 g/L • Renal function- Creatinine 50 mL/min.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Benefit of Progression Free Survival (PFS) during first 12 monthsTimepoint: One year after completion of study recruitment or as per study requirement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Response Rate (ORR) 2. Disease Control Rate (DCR) 3. Overall Survival (OS) Time Frame 4. Event Free Survival (EFS) 5. Quality of life (QOL) 6. To assess if there are any factors that can predict which patients are more likely to benefit from with customized therapy approach compared to standard of care approach. 7. To assess the rate of adverse events 8. To assess the time to deterioration of ECOG performance score 9. To evaluate PFS benefit beyond initial 12 months Timepoint: Approximately one year after study recruitment completion / as per study requirement | — |
Countries
India
Contacts
Public ContactDr Darshana Patil
Datar Cancer Genetics Limited
Outcome results
None listed