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CTRI Number  CTRI/2023/10/058358 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Triple drug therapy in advanced gall bladder cancer 
Scientific Title of Study   Gemcitabine, Oxaliplatin and Capecitabine in locally advanced unresectable/metastatic gall bladder carcinoma: an investigator-initiated phase 2 trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash Kumar 
Designation  assistant Professor 
Affiliation  NCI AIIMS 
Address  Department of Medical Oncology First floor Academic Block National Cancer Institute AIIMS Jhajjar campus Village Badsa District Jhajjar Haryana

Jhajjar
HARYANA
124105
India 
Phone  01251274776  
Fax    
Email  akashjha08@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Akash Kumar 
Designation  assistant Professor 
Affiliation  NCI AIIMS 
Address  Department of Medical Oncology First floor Academic Block National Cancer Institute AIIMS Jhajjar campus Village Badsa District Jhajjar Haryana


HARYANA
124105
India 
Phone  01251274776  
Fax    
Email  akashjha08@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Akash Kumar 
Designation  Assistant Professor 
Affiliation  NCI AIIMS 
Address  Department of Medical Oncology First floor Academic Block National Cancer Institute AIIMS Jhajjar campus Village Badsa District Jhajjar Haryana

Jhajjar
HARYANA
124105
India 
Phone  01251274776  
Fax    
Email  akashjha08@yahoo.com  
 
Source of Monetary or Material Support  
NONE 
 
Primary Sponsor  
Name  NCI, AIIMS 
Address  Department of Medical Oncology First floor Academic Block National Cancer Institute AIIMS Jhajjar campus Village Badsa District Jhajjar Haryana 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akash Kumar  National Cancer Institute, AIIMS - jhajjar campus  Department of medical Oncology, 1st floor, Academic Block, National Cancer Institute, AIIMS- Jhajjar campus, Vill- Badsa, Dist - Jhajjar, Haryana
Jhajjar
HARYANA 		 011-27514776

akashjha08@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gemcitabine, Oxaliplatin and Capecitabine  Inj Gemcitabine @ 1gm/m2, Day -1 & 8 Inj Oxaliplatin @ 130mg/m2, Day -1 Tab Capecitabine@ 650mg/m2 BD, D1-14 Cycle every 21 days for 8 cycles f/b Capecitabine maintenance @ 1250mg/m2 BD till toxicity or progression or death  
Comparator Agent  not applicable  none 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ECOG PS – 0-2
2. Patients must have histologically or cytologically confirmed gallbladder cancer
3.Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease. Must have been completed within 28 days prior to registration.
4. Visceral measurable metastases (at least one lesion > 10mm) and/or measurable and non resectable primary tumor, histopathological (or cytological) proven disease (metastasis or primary site). If there is no visceral metastasis, non-resectability should be confirmed by a hepato-biliary surgeon in a multi-disciplinary meeting.
5. Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer
6. Patient must not have received adjuvant therapy within 6 months prior to registration
7. No prior malignancy or dual malignancy
8. Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
9. Must give informed consent before study initiation.
10. Absolute neutrophil count (ANC)  1,500/mcL (obtained within 28 days prior to registration)
11. Platelets  100,000/mcL (obtained within 28 days prior to registration)
12. Hemoglobin 8 g/dL (obtained within 28 days prior to registration)
13. Serum albumin2.8 g/dL (obtained within 28 days prior to registration)
13. Total bilirubin ï‚£ 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to registration)
15. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ï‚£ 8 x IULN (obtained within 28 days prior to registration)
16. Serum creatinine  IULN OR calculated creatinine clearance  60 mL/min (obtained within 28 days prior to registration)
17. Neuropathy- no pre-existing history of peripheral neuropathy > grade 1
18. No history of previous malignancy/ chemotherapy/ radiotherapy
19. No other serious illness leading to inability to participate in the trial as assessed by the physician
 
 
ExclusionCriteria 
Details  1. Non-measurable metastases and primary tumour
2. Major comorbidity factors (unstable angina, myocardial infarction that has occurred within the last 6 months, heart failure ≥2 according to the NYHA classification, uncontrolled high blood pressure
3. Immunocompromised state
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Progression Free Survival  every three monthly till disease progression or death , for upto 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
A. Overall survival
B. Overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
C. Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
 		 6 months 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   09/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Prognosis of locally advanced unresectable and/or metastatic gall bladder cancer is dismal. The overall survival is around 12 months. Gemcitabine and Platin  ( Gemcitabine + CDDP /  Gemcitabine + Oxaliplatin ) based doublet has long been the mainstay of treatment. Intensification of chemotherapy with addition of Nab-paclitaxel for improving outcomes has failed recently . Addition of targeted therapies like Durvalumab and Pembrolizumab has showed promising outcomes in biliary tract tumours, however, representation of gall bladder cancers in these study cohorts has been limited. A triple drug combination of Gemcitabine , Oxaliplatin and Capecitabine has been found to be an effective combination in few small phase 2 studies of carcinoma pancreas and biliary tract, with a manageable toxicity profile. This study is undertaken to assess if this triple drug combination is efficacious in improving survival as a first line palliative chemotherapy in carcinoma gall bladder. 

 
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