Comparative efficacy of therapy based comprehensive molecular and in-vitro studies versus standard of care therapy in newly diagnosed therapy naïve advanced/unresectable malignancies

Phase 2

• Conditions: Health Condition 1: C00-D49- NeoplasmsHealth Condition 2: null- Newly diagnosed therapy naïve advanced/unresectable gallbladder cancer, cholangiocarcinoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer, esophageal cancer and glioblastoma patients

• Registration Number: CTRI/2018/05/014178
• Lead Sponsor: Datar Cancer Genetics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 <= 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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified