Addition of Everolimus to Standard of Care in Carcinoma Gallbladder

A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder - GBC01

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052625

Enrollment

Registered

2023-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: Everolimus: Everolimus 10 mg orally D1-D21, in addition to standard of care chemotherapy i.e. CapOx or GemOx Control Intervention1: Chemotherapy: CapOx Capecitabine 825mg/m2 D1-14 with

Eligibility

Inclusion criteria

Inclusion criteria: Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment. Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine/capecitabine with or without platinum more than months ago as part of adjuvant therapy

Exclusion criteria

Exclusion criteria: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness orsocial situations that would limit compliance with study requirements Clinically significant cardiac disease, especially history of myocardial infarction more than 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias Patients taking strong inhibitors or inducers of CYP3A4 Prior therapy with everolimus

Design outcomes

Primary

Measure	Time frame
Disease free survival Overall survival Timepoint: 12 months	—

Secondary

Measure	Time frame
Toxicity as per WHO toxicity criteriaTimepoint: Every 3 weeks	—

Countries

India

Contacts

Public Contactmadhumita Tripathi

Institute of Medical Sciences, BHU

mpandey66@bhu.ac.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026