Triple drug therapy in advanced gall bladder cancer

Phase 2

• Conditions: Health Condition 1: C23- Malignant neoplasm of gallbladder

• Registration Number: CTRI/2023/10/058358
• Lead Sponsor: CI, AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. ECOG PS – 0-2

2. Patients must have histologically or cytologically confirmed gallbladder cancer

3.Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease. Must have been completed within 28 days prior to registration.

4. Visceral measurable metastases (at least one lesion > 10mm) and/or measurable and non resectable primary tumor, histopathological (or cytological) proven disease (metastasis or primary site). If there is no visceral metastasis, non-resectability should be confirmed by a hepato-biliary surgeon in a multi-disciplinary meeting.

5. Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer

6. Patient must not have received adjuvant therapy within 6 months prior to registration

7. No prior malignancy or dual malignancy

8. Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method.

9. Must give informed consent before study initiation.

10. Absolute neutrophil count (ANC) ? 1,500/mcL (obtained within 28 days prior to registration)

11. Platelets ? 100,000/mcL (obtained within 28 days prior to registration)

12. Hemoglobin ?8 g/dL (obtained within 28 days prior to registration)

13. Serum albumin?2.8 g/dL (obtained within 28 days prior to registration)

13. Total bilirubin ? 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to registration)

15. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ? 8 x IULN (obtained within 28 days prior to registration)

16. Serum creatinine ? IULN OR calculated creatinine clearance ? 60 mL/min (obtained within 28 days prior to registration)

17. Neuropathy- no pre-existing history of peripheral neuropathy > grade 1

18. No history of previous malignancy/ chemotherapy/ radiotherapy

19. No other serious illness leading to inability to participate in the trial as assessed by the physician

Exclusion Criteria

1.Non-measurable metastases and primary tumour

2.Major comorbidity factors (unstable angina, myocardial infarction that has occurred within the last 6 months, heart failure =2 according to the NYHA classification, uncontrolled high blood pressure

3.Immunocompromised state

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free SurvivalTimepoint: every three monthly till disease progression or death , for upto 2 years

Secondary Outcome Measures

Name	Time	Method
A.Overall survival <br/ ><br>B.Overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria <br/ ><br>C.Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 <br/ ><br>Timepoint: 6 months