Interventional Recruiting Phase 2/Phase 3
NCT05833815 on ClinicalTrials.gov
Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Official title: A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
- Sponsor: Banaras Hindu University
- Enrollment: 56 (Estimated)
- Study start: 2022-11-01 (Actual)
- Primary completion: 2024-12-30 (Estimated)
- Study completion: 2024-12-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Participant)
- PrimaryPurpose: Treatment
Brief Summary
Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.
Conditions
- Gallbladder Cancer
Intervention / Treatment
- Drug: Everolimus 10 mg
- Drug: Standard of care
Primary Outcome Measures
-
Progression free survival
(12 months)
Progression free survival from diagnosis to disease progression or death
Countries
India
Locations and Investigators
-
Banaras Hindu University, Varanasi, India (Recruiting)
- Manoj Pandey