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New treatment option for Gall Bladder Carcinoma
Official title Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
ClinicalTrials.gov ID: NCT06712420
What this study is testing
What is neoadjuvant chemotherapy?
neoadjuvant chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gall bladder carcinoma.
Also referred to as NACT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
- Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
- Post cholecystectomy GBC without any evidence of spillage of residual disease 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
See the full eligibility 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...
- Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
- Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
- Post cholecystectomy GBC without any evidence of spillage of residual disease 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
The study team makes the final eligibility decision.
Where it's taking place
- Delhi, National Capital Territory of Delhi, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Delhi, National Capital Territory of Delhi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.