Study of Losartan and Standard of care therapy in advanced biliary tract cancer

Study of losartan and SOC therapy in advanced biliary tract cancer - LAST STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049523

Enrollment

Registered

2023-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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: Tab Losartan Drug: Tab Losartan medication given to all gall bladder carcinoma patient as per inclusion criteria Intervention2: no controlled grou[: not applicable Intervention3: tab Lo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18years 2. Patients with unresectable or metastatic gallbladder cancer 3. Patients with extra intra hepatic cholangiocarcinoma 4. ECOG PS 0-2 5. Adequate organ function 6. Bilirubin 7. Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion criteria: 1. Patients with GFR 2. Pregnant women and breastfeeding women 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 4. Uncontrolled intercurrent infection or other uncontrolled medical illness 5. Active psychiatric illness which would limit compliance 6. Patient with more than 2 antihypertensive medications 7. Patient who are already undergoing chemotherapy (already diagnosed case started on chemotherapy)

Design outcomes

Primary

Measure	Time frame
main aim of the study is repurposing of drug - That is tab losartan will increase the penetration of chemotherapy drugs into the tumors cell effectively - measured by increase the survival of patient for more than 9 month ( normally chemotherapy had survival of 6 month duration) in a sample size of 25 patient and the study will end after 9 months Timepoint: initially at the time of starting chemotherapy then on 3rd month ( after completing 3 cycle chemotherapy ) and 6th month after competing 6th chemotherapy, then onwards Every 3 months patients will be analyzed for events	—

Measure

Time frame

main aim of the study is repurposing of drug - That is tab losartan will increase the penetration of chemotherapy drugs into the tumors cell effectively - measured by increase the survival of patient for more than 9 month ( normally chemotherapy had survival of 6 month duration) in a sample size of 25 patient and the study will end after 9 months Timepoint: initially at the time of starting chemotherapy then on 3rd month ( after completing 3 cycle chemotherapy ) and 6th month after competing 6th chemotherapy, then onwards Every 3 months patients will be analyzed for events

—

Secondary

Measure	Time frame
secondary outcome is event or death Timepoint: out come will be assessed ever 3rd month until death or lost follow up	—

Countries

India

Contacts

Public ContactDr Kiran Kumar Ponugumati

INHS Asvini

dr.amolpatel@gmail.com9999856335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 29, 2026