A study for advanced stage gall bladder cancer patients who are not fit to receive chemotherapy

Three arm phase II/III Randomized Controlled Trial in patients with unresectable/metastatic Gall Bladder Cancer with poor performance status-Best supportive care/Erlotinib/Capecitabine

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018860

Enrollment

116

Registered

2019-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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.Erlotinib: 150 mg OD PO starting dose Intervention2: Erlotinib: Tab.Erlotinib 150 mg PO OD starting dose in addition to current standard of care (best supportive care),until progres

Eligibility

Inclusion criteria

Inclusion criteria: cytologically/pathologically confirmed Gall bladder cancer patients with poor performance status with adequate marrow and organ function,adjuvant chemotherapy if given should have been completed more than six months ago

Exclusion criteria

Exclusion criteria: Active malignancy other than biliary tract cancer,impaired liver function tests despite biliary drainage,lactating and pregnant women,previous exposure to Erlotinib or Capecitabine within six months,HIV positive patients

Design outcomes

Primary

Measure	Time frame
Overall SurvivalTimepoint: Six months	—

Secondary

Measure	Time frame
Clinical benefit responseTimepoint: Six to eight weeks;Progression free survivalTimepoint: Six to eight weeks;Quality of LifeTimepoint: Baseline,Six to eight weeks ,every four weeks thereafter.;To study soluble hepatocyte growth factor in tissue and blood samplesTimepoint: Baseline and at six to eight weeks	—

Countries

India

Contacts

Public ContactBabita

All India Institute of Medical Sciences

atul1@hotmail.com011-29575226

Outcome results

None listed

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