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CTRI Number  CTRI/2023/02/049523 [Registered on: 07/02/2023] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Study of Losartan and Standard of care therapy in advanced biliary tract cancer 
Scientific Title of Study   Study of losartan and SOC therapy in advanced biliary tract cancer 
Trial Acronym  LAST STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amol N Patel 
Designation  Medical Oncologist , Associate Professor Dept. of Medicine  
Affiliation  INHS Asvini 
Address  Medical Oncologist Department of Medicine INHS Asvini, Colaba , mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9999856335  
Fax    
Email  dr.amolpatel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amol N Patel 
Designation  Medical Oncologist , Associate Professor Dept. of Medicine  
Affiliation  INHS Asvini 
Address  Medical Oncologist Department of Medicine INHS Asvini, Colaba , mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9999856335  
Fax    
Email  dr.amolpatel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kiran Kumar Ponugumati 
Designation  Medicine Resident 
Affiliation  INHS Asvini 
Address  Medicine Resident, Department of medicine, INHS Asvini, Colaba, Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9966640231  
Fax    
Email  kirankumar2064@gmail.com  
 
Source of Monetary or Material Support  
Study is conducted in INHS Asvini. Tab losartan will supplied by central drug store in INHS Asvini for free of cost 
 
Primary Sponsor  
Name  INHS ASVINI 
Address  INHS Asvini, Colaba, Near RC Church gate, Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Kumar P  INHS ASVINI  INHS asvini, Colaba, Mumbai
Mumbai
MAHARASHTRA 
9966640231

kirankumar2064@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INHS Asvini ethics committee  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 
Comparator Agent  NIL  NIL 
Intervention  tab Losartan   initially started with with 25mg OD dose per oral and gradually increase up to 100 mg depend on patient vitlas for a period of 9 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Age more than 18years
2. Patients with unresectable or metastatic gallbladder cancer
3. Patients with extra intra hepatic cholangiocarcinoma
4. ECOG PS 0-2
5. Adequate organ function
6. Bilirubin <5 mg/dl
7. Ability to understand and the willingness to sign a written informed consent document
 
 
ExclusionCriteria 
Details  1. Patients with GFR<50 ml/min
2. Pregnant women and breastfeeding women
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
4. Uncontrolled intercurrent infection or other uncontrolled medical illness
5. Active psychiatric illness which would limit compliance
6. Patient with more than 2 antihypertensive medications
7. Patient who are already undergoing chemotherapy (already diagnosed case started on chemotherapy)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
main aim of the study is repurposing of drug - That is tab losartan will increase the penetration of chemotherapy drugs into the tumors cell effectively - measured by increase the survival of patient for more than 9 month ( normally chemotherapy had survival of 6 month duration) in a sample size of 25 patient and the study will end after 9 months
 
initially at the time of starting chemotherapy then on 3rd month ( after completing 3 cycle chemotherapy ) and 6th month after competing 6th chemotherapy, then onwards Every 3 months patients will be analyzed for events
 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcome is event or death
 
out come will be assessed ever 3rd month until death or lost follow up
 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   13/02/2023 
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   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.amolpatel@gmail.com].

  6. For how long will this data be available start date provided 25-11-2022 and end date provided 25-11-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Among biliary tract cancers, Gall bladder cancer (GBC) is the commonest malignancy with typical geographic distribution. GBC incidence is high in north and north-eastern India. As per Delhi cancer registry, GBC is the third common cancer in females with ASR of 10/100000 population. In India each year >18,000 new gall bladder cancers are diagnosed.  More than 80% present in advanced/unresectable stage and median survival of untreated patient is 2-4 months.

It is highly aggressive cancer having poor outcomes across the globe. It is the commonest cause of cancer related death in

Chile and in northern India (1).  GBC has certain peculiarities like anatomical location which makes the detection of cancer difficult in early stages. It presents with obstructive jaundice which precludes early start of chemotherapy and for many patients best supportive care is the only treatment offered.

Atul Sharma et al first studied the role of chemotherapy versus best supportive care in advanced gall bladder cancer (2) and established the role of chemotherapy.  Genetically, majority of gall bladder cancers are carrying p53 mutations which may lead to resistance to chemotherapy. Combination of Gemcitabine and Platinum; Gemcitabine-Cisplatin (Gem-Cis) or modified Gemcitabine-Oxaliplatin (mGemOx) are first line therapy for metastatic/unresectable GBC based on randomized studies (3). Five-year survival rates of gall bladder cancers are 50% for stage I, 28% for stage II, and less than 10% for inoperable stage III cancers. This suggests that even curative surgery is not successful in majority of GBC patients whose tumor has spread beyond muscle layer or has involved lymph nodes. GBC has tendency for both loco-regional and distant failures. It may involve surrounding adjacent structures such as the liver, stomach, duodenum, pancreas, colon, omentum, or abdominal wall. Recent publications have highlighted the importance of targeted therapies in biliary tract cancers. Gall bladder cancer is enriched with Her2neu amplification in 17-20% of cases, Her3neu amplification in 10 % of cases. MET amplifications are seen in around 5% of cases (4–6). These targets have been treated successfully in other malignancies and are routinely used in clinical practice. At our institute, our data from departmental study has also revealed similar findings in limited number of patients (3). This merits to take forward this research, which will answer the long-awaited questions in advanced biliary tract cancers.

 

 

Biliary tract cancers (BTCs) have varied and unique incidence pattern and it has increasing trend. In some part of the world, these are the commonest cancers. Cholangiocarcinoma (CCA) is most common cancer in Thailand (north east region) with age standardised rate (ASR) per 100,000 populations of 85 and it is least common in Europe (ASR < 2) & United States (ASR 2.2) (7). Interestingly, incidence varies in different parts of the county. In Thailand’s north east region, it is the most common as mentioned, ASR is 14.5 and 5.7 in North-central and South region respectively. Similarly, Gallbladder cancer (GBC) has varied incidence pattern across in India. In northern states of India, it is the most common and in southern states it is the least common (8,9).

Rarity in western world, precluded BTCs from research in field of targeted and molecular therapies. The prognosis of GBC has not changed in last 20 years (10). Gemcitabine with Cisplatin or Oxaliplatin remained the standard of choice of treatment in metastatic BTCs as first line setting and there is no established second line therapy available till date(11,12). CCA are classified as intra-hepatic (iCCA), perihilar (pCCA) and distal CCA (dCCA). CCA and GBC are treated altogether in clinical trials considering their anatomical location, physiological common functions and clinical presentations. Rapid progress has been made as the next generation sequencing (NGS) reduce the time and hundreds of genes analysed at one go (13).

 

 

 

 

References

 

1.         Malhotra RK, Manoharan N, Shukla NK, Rath GK. Gallbladder cancer incidence in Delhi urban: A 25-year trend analysis. Indian Journal of Cancer. 2017 Jan 10;54(4):673.

2.         Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, et al. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581–6.

3.         Sharma A, Shukla NK, Chaudhary SP, Sahoo R, Mohanti B, Deo SVS, et al. Final results of a phase III randomized controlled trial comparing modified gemcitabine + oxaliplatin (mGEMOX) to gemcitabine+ cisplatin in management of unresectable gall bladder cancer (GBC). JCO. 2016 May 20;34(15_suppl):4077–4077.

4.         Galdy S, Lamarca A, McNamara MG, Hubner RA, Cella CA, Fazio N, et al. HER2/HER3 pathway in biliary tract malignancies; systematic review and meta-analysis: a potential therapeutic target? Cancer Metastasis Rev. 2017;36(1):141–57.

5.         Javle M, Rashid A, Churi C, Kar S, Zuo M, Eterovic AK, et al. Molecular Characterization of Gallbladder Cancer using Somatic Mutation Profiling. Hum Pathol. 2014 Apr;45(4):701–8.

6.         Javle M, Churi C, Kang HC, Shroff R, Janku F, Surapaneni R, et al. HER2/neu-directed therapy for biliary tract cancer. J Hematol Oncol. 2015 May 29;8:58.

7.         Khan SA, Tavolari S, Brandi G. Cholangiocarcinoma: Epidemiology and risk factors. Liver Int. 2019;39 Suppl 1:19–31.

8.         Shukla HS, Sirohi B, Behari A, Sharma A, Majumdar J, Ganguly M, et al. Indian Council of Medical Research consensus document for the management of gall bladder cancer. Indian J Med Paediatr Oncol. 2015;36(2):79–84.

9.         Unisa S, Jagannath P, Dhir V, Khandelwal C, Sarangi L, Roy TK. Population-based study to estimate prevalence and determine risk factors of gallbladder diseases in the rural Gangetic basin of North India. HPB. 2011;13(2):117–25.

10.       Lindnér P, Holmberg E, Hafström L. Gallbladder cancer – no improvement in survival over time in a Swedish population. Acta Oncologica. 2018 Nov 2;57(11):1482–9.

11.       Valle JW, Furuse J, Jitlal M, Beare S, Mizuno N, Wasan H, et al. Cisplatin and gemcitabine for advanced biliary tract cancer: a meta-analysis of two randomised trials. Ann Oncol. 2014 Feb;25(2):391–8.

12.       Ying J, Chen J. Combination versus mono-therapy as salvage treatment for advanced biliary tract cancer: A comprehensive meta-analysis of published data. Critical Reviews in Oncology/Hematology. 2019 Jul 1;139:134–42.

13.       Lee H, Ross JS. The potential role of comprehensive genomic profiling to guide targeted therapy for patients with biliary cancer. Therap Adv Gastroenterol. 2017 Jun;10(6):507–20.

 


 
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