Gall Bladder CarcinomaPhase 3NEOGBNCT06712420
Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
A Phase 3 study testing neoadjuvant chemotherapy and curative surgery in people with Gall Bladder Carcinoma, run by Rajiv Gandhi Cancer Institute & Research Center, India at 3 sites in India.
Trial summary
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gall Bladder Carcinoma
- What is being tested?
- neoadjuvant chemotherapy and curative surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesIndia
- Study dates
- 1 Jan 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, National Capital Territory of Delhi, 110085
Shivendra Singh, Mch, +919818975024, shiven_24@yahoo.co.in
Shaifali Goel, DrNB, +918368382060, doctor.shaifali@gmail.com
- Recruiting
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, National Capital Territory of Delhi, 110085
Shivendra Singh, Mch Surgical Gastroenterology, +919818975024, shiven_24@yahoo.com
Shaifali Goel, DrNB Surgical Gastroenterology, +918368382060, doctor.shaifali@gmail.com
- Recruiting
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, National Capital Territory of Delhi, 110085
About this study
Official title: Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Read the detailed description
Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.
The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.
Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.
- Conditions
- Gall Bladder Carcinoma
- Being tested
- neoadjuvant chemotherapy, curative surgery
- Keywords
- gallbladder, locally advanced, neoadjuvant
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyDrug
Also called NACT
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 surgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| upfront surgery | Experimental | 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 Receives: Procedure: curative surgery |
| Neoadjuvant chemotherapy followed by surgery | Experimental | 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. Receives: Drug: neoadjuvant chemotherapy; Procedure: curative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in 3 year overall survival
To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer
Measured: 3 year
Secondary outcomes (1)
post operative outcomes
To compare mortality and morbidity rate in two groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaifali Goel, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Shivendra Singh, Mch Surgical gastroenterology, Study director, Rajiv Gandhi Cancer Institute and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712420
- Sponsor's protocol ID
- RGCIRC/IRB-BHR/26/2024
- Other IDs
- RES/SCM/61/2023/89
- Acronym
- NEOGB
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Institutional Policy
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
- ClinicalTrials.gov ID
- NCT06712420
- Acronym / sponsor ID
- NEOGB / RGCIRC/IRB-BHR/26/2024
- Conditions
- Gall Bladder Carcinoma
- Keywords
- gallbladder, locally advanced, neoadjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Detailed description
Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.
The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.
Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upfront surgery | Experimental | Procedure: curative surgeryafter 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 |
| Neoadjuvant chemotherapy followed by surgery | Experimental | Drug: neoadjuvant chemotherapy, Procedure: curative surgeryNACT 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapyAlso: NACTNACT 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 | Drug | Neoadjuvant chemotherapy followed by surgery |
| curative surgeryPatient 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 | Procedure or surgery | Neoadjuvant chemotherapy followed by surgery, upfront surgery |
Primary outcome
improvement in 3 year overall survival
Time frame: 3 year
To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer
1 secondary outcome
post operative outcomes
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. Institutional Policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivendra Singh, Mch Surgical gastroenterology study director
Rajiv Gandhi Cancer Institute and Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neoadjuvant chemotherapy and curative surgery in people with Gall Bladder Carcinoma, run by Rajiv Gandhi Cancer Institute & Research Center, India at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivendra Singh, Mch (+919818975024, shiven_24@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in 3 year overall survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.