Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)

NCT06712420 · tracked via the Priya Life Science India tracker

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Phase

Phase 3

Started

2025-01-01

Last updated

2025-04-16

Condition(s) studied

Gall Bladder Carcinoma

Investigational drug(s) / intervention(s)

neoadjuvant chemotherapycurative surgery

neoadjuvant chemotherapy: NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. PAtients will undergo curative surgery after neoadjuvant chemotherapy

curative surgery: Patient being taken up for surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification

Study summary

to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * ECOG 0-2 * Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies. * Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies. Exclusion Criteria: 1. Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging . 2. Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy. 3. Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging. 4. Obstructive jaundice due to involvement of biliary tree by tumour. 5. Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein. 6. Any distant metastasis or isolated port site metastasis 7. Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN). 8. Poor performance status ECOG 3 or more. 9. Pregnancy. 10. Inability or unwillingness to follow study protocol

Primary outcome measure(s)

improvement in 3 year overall survival — 3 year
To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer

Trial sites (3)

Facility	City	Region	Status
Rajiv Gandhi Cancer Institute and Research Centre	Delhi	National Capital Territory of Delhi	Recruiting
Rajiv Gandhi Cancer Institute and Research Centre	Delhi	National Capital Territory of Delhi	Recruiting
Rajiv Gandhi Cancer Institute and Research Centre	Delhi	National Capital Territory of Delhi	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712420 on ClinicalTrials.gov ↗ ← All trials in India