Doublet chemotherapy (Gemcitabine and Cisplatin) vs triplet chemotherapy (Gemcitabine, Cisplatin and Nab-paclitaxel) in locally advanced or metastatic gall bladder cancer patients.

Comparing the outcome of doublet therapy (Gemcitabine and Cisplatin) with triplet therapy (Gemcitabine, Cisplatin and nab-paclitaxel) in locally advanced or metastatic gall bladder cancer patients, an open randomized control trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036362

Enrollment

Registered

2021-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Nab paclitaxel: Arm B - Gemcitabine 1000mg/m2 intravenously Day 1 and 8,Cisplatin 25 mg/m2 intravenously Day 1 and 8,Nab-paclitaxel 125 mg/m2intravenously Day 1 and 8 every 21 days fo

Eligibility

Inclusion criteria

Inclusion criteria: 1)Locally advanced or metastatic gall bladder cancer patients proven histologically and on imaging [contrast enhanced CT scan of chest, abdomen and pelvis / MRI abdomen and pelvis with CECT chest /whole body PET CT scan] 2)ECOG performance 0-2 3)Adequate renal functions [Creatinine Clearance >60mL/min] 4)Adequate hepatic functions [serum bilirubin 5)Adequate hematological parameters [ Hemoglobin >8g/dL , platelet count > 1 lakh, ANC >1500/ul]

Exclusion criteria

Exclusion criteria: 1)Patients who fail to give consent 2)Patients who have received prior systemic chemotherapy for current malignancy

Design outcomes

Primary

Measure	Time frame
PRIMARY OBJECTIVE: To determine the Response Rate (RR) based on Radiological Response as per RECIST or PRECIST.Timepoint: Response Rate - Complete response or partial response as per RECIST or PRECIST after 3 and after 6 cycles of chemotherapy.	—

Secondary

Measure	Time frame
SECONDARY OBJECTIVES: 1. To determine Progression Free Survival (PFS) and Overall Survival (OS) 2. To evaluate the toxicities according to NCI-CTC v 4.0. 3. To correlate clinico-demographic profile and laboratory features. Timepoint: 1.Progression free survival at 6 months, at 12 months and at 18 months and Overall survival at 6 months, at 12 months and at 18 months. 2.Toxicities according to NCI-CTC V 4.0 after each cycle of chemotherapy then at 6 months, at 12months and at 18 months. 3. Clinico-demographic profile will be recorded at baseline and serum tumors marker ( CA 19.9) will be recorded at baseline, after 3 cycles and 6 cycles and at 6 months,at 12 months ,at 18 months follow up.	—

Measure

Time frame

SECONDARY OBJECTIVES: 1. To determine Progression Free Survival (PFS) and Overall Survival (OS) 2. To evaluate the toxicities according to NCI-CTC v 4.0. 3. To correlate clinico-demographic profile and laboratory features. Timepoint: 1.Progression free survival at 6 months, at 12 months and at 18 months and Overall survival at 6 months, at 12 months and at 18 months. 2.Toxicities according to NCI-CTC V 4.0 after each cycle of chemotherapy then at 6 months, at 12months and at 18 months. 3. Clinico-demographic profile will be recorded at baseline and serum tumors marker ( CA 19.9) will be recorded at baseline, after 3 cycles and 6 cycles and at 6 months,at 12 months ,at 18 months follow up.

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Countries

India

Contacts

Public ContactDr Chandrani Khatri

Indraprastha Apollo Hospital

drpratapdas@gmail.com09810444600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026