Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06712420

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

Led by Rajiv Gandhi Cancer Institute & Research Center, India · Updated on 2025-04-16

114

Participants Needed

3

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status 0 to 2
  • Locally advanced resectable gallbladder cancer defined as clinical T3 or T4 disease or regional lymph node involvement on imaging
  • Post cholecystectomy gallbladder cancer with residual disease on imaging, history of bile spillage during initial surgery, or piece-meal gallbladder removal during simple cholecystectomy with regional lymph node involvement on imaging
Not Eligible

You will not qualify if you...

  • Early gallbladder cancer (cT1 or cT2) without significant lymphadenopathy or liver infiltration on imaging
  • Locally advanced disease requiring major hepatectomy or Whipple's pancreatoduodenectomy
  • Post cholecystectomy gallbladder cancer without evidence of spillage or residual disease on imaging
  • Obstructive jaundice due to tumor involvement of the biliary tree
  • Vascular involvement such as common hepatic artery, main portal vein, right hepatic artery, or right portal vein
  • Any distant metastasis or isolated port site metastasis
  • Involvement of non-regional lymph nodes (e.g., celiac, superior mesenteric artery, inter-aortocaval, or left para-aortic lymph nodes)
  • Poor performance status with ECOG 3 or higher
  • Pregnancy
  • Inability or unwillingness to follow the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India, 110085

Actively Recruiting

2

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India, 110085

Actively Recruiting

3

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India, 110085

Actively Recruiting

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Research Team

S

Shivendra Singh, Mch

CONTACT

S

Shaifali Goel, DrNB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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