NCT06712420RecruitingPhase 3
Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 22 Oct 2024
- Start date
- 1 Jan 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06712420
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 114
- From 1 Jan 2025 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
- Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.
Other
- Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
- Obstructive jaundice due to involvement of biliary tree by tumour.
- Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein.
- Any distant metastasis or isolated port site metastasis
- Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN).
- Poor performance status ECOG 3 or more.
- Pregnancy.
- Inability or unwillingness to follow study protocol
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rajiv Gandhi Cancer Institute and Research Centre Coordinator of this site? Confirm its status | Delhi | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.