Clinical trial · Interventional
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
NCT06712420CI-TRIAL-00088623NEOGBrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gall Bladder Carcinoma | Gallbladder Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curative surgery | Procedure | — | UNRESOLVED |
| neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- upfront surgery
- description
- after staging workup and biopsy, patient being taken up for upfront 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
- interventionNames
- Procedure: curative surgery
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy followed by surgery
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.