Hepatocellular CarcinomaNCT04443049
To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.
A study testing Lenvatinib and Mebendazole in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Currently the available first line palliative therapy for advanced HCC is Sorafenib and Lenvatinib of which Lenvatinib is tolerated better. Unfortunately, patients tend to progress after few months of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis
- What is being tested?
- Lenvatinib and Mebendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jul 2020to 19 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Cirrhosis of Liver with HCC on imaging and/or biopsy or cytology
- Child Pugh A, Child Pugh B < 8
- Advanced HCC - as defined by BCLC - C
- ECOG Performance Status 1-2
- Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at screening and no change in antihypertensive therapy within 1 week prior to commencement of intervention.
- Valid Consent
- Age 18-70 years
Who cannot join
- Decompensated Cirrhosis
- Child Pugh C, Child Pugh B > 7
- HCC patients with a curative therapy (RFA/MWA or LT)
- Prior systemic therapies (or) immunotherapy for HCC
- ECOG Performance Status 3-4
- Post Liver transplant HCC recurrence
- Pregnancy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Naveen Kumar, MD, 01146300000, navinktanvi10@gmail.com
About this study
Currently the available first line palliative therapy for advanced HCC is Sorafenib and Lenvatinib of which Lenvatinib is tolerated better. Unfortunately, patients tend to progress after few months of therapy. Therefore it is imperative, to do trials by combinative therapy to the available therapy for added survival benefits and quality of life with advanced HCC. In this regard, Mebendazole appears to be a good choice for drug repurposing as it has shown very promising results either alone or in combination with other therapies in tumors of GI origin and CNS tumors. With regard to HCC Mebendazole has been found to be effective in vitro system of HCC and preclinical models. However no clinical trials have been initiated till now. The key hallmark features of HCC include activation of MAPK and angiogenesis which in turn are targeted by RTK inhibitors such as Sorafenib and Lenvatinib. In this regard Mebendazole has broad range of action by not only inhibiting angiogenesis and pro-survival pathways of MAPK, but by also inhibiting the secretion of MMPs and Tubulin polymerization which can all be beneficial in tumor regression and prevention of chemo-resistance in HCC. Mounting of a strong immune response plays an important role in identification of tumor antigen and thereby clearing of tumors. While Mebendazole can modulate the tumor, the data is scant with respect to the role of the drug. Hence repurposing Mebendazole as a combinatorial therapy appears a promising approach and forms the basis of the present work. We hypothesize that combinatorial therapy of addition of mebendazole to lenvatinib will prove more beneficial than lenvatinib alone in increasing the overall survival of patients with advanced HCC. To prove the mechanistic effects of mebendazole on HCC, we will also conduct a animal study in preclinical mice model of HCC with the help of our animal house facility. The animal study will help us to understand the additional benefits from mebendazole and lenvatinib with objective evidence of liver biopsy which is not feasible in humans.
Read the detailed description
(A) STUDY HYPOTHESIS
- Mebendazole augments response of lenvatinib by synergistic response.
- Addition of anti angiogenic drugs (lenvatinib and mebendazole) to hypoxic environment generated post locoregional therapy like TACE leads to more effective control of advanced HCC resulting in improvement in overall survival. (B) AIM: To compare the efficacy of combination of mebendazole with lenvatinib in cirrhotics with advanced Hepatocellular Carcinoma. (C) OBJECTIVE:
Primary objective:
To compare the efficacy of combination of mebendazole with lenvatinib in improving the overall survival at 15 months in cirrhotics with advanced HCC.
Secondary objective:
- To compare the progression free survival with combination therapy of mebendazole and lenvatinib in advanced Hepatocellular Carcinoma (HCC).
- To compare the objective response rate (ORR), disease control rate (DCR) and clinical benefit rate (CBR) with combinative therapy of mebendazole and lenvatinib in advanced HCC.
- To study therapy related adverse effects of mebendazole in cirrhotics.
- To develop pre-clinical HCC animal model to prove the added efficacy of combination therapy. (D)STUDY DESIGN Type of study - Single center, prospective, open label, randomized control study Study population - cirrhosis of liver of any etiology with advanced HCC undergoing at ILBS Study duration - 22 months from the date of approval of IEC Sample size - Considering mebendazole adds 2 months more to lenvatinib which offers 13 months overall survival, power of the study as 80 %, attrition rate as 30 %, alpha error of 5%, sample size will be 85 patients in each arm ( totally 170 patients). (F) Methodology: Cirrhotics with advanced HCC proven by imaging and or biopsy or cytology, fulfilling the eligibility criteria will be enrolled in the study. They may undergo 1 or 2 sessions of locoregional therapy (TACE/ SBRT/RFA) if feasible. All patients will undergo complete physical examination, CBC, LFT, KFT, INR, AFP, PIVKAII, CEMRI/ CECT upper abdomen (Triple phase ), UGI endoscopy at baseline before randomization.
Randomization:
Those patients who are not feasible for locoregional therapy will be randomized at baseline. Those patients undergoing locoregional therapy will be randomized after 1 month of last locoregional therapy (patient may undergo maximum of two sessions of locoregional therapy before randomization). The response will be determined by m RECIST criteria before randomization. Those patients requiring further sessions of locoregional therapy beyond two sessions will not be randomized into study.
Patient will be then randomized to one of the two groups Arm I :Lenvatinib +Placebo( Lenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg ) with placebo (Tab Mecovit) orally twice a day (BD) daily Arm II : Lenvatinib and mebendazole ( Lenvatinib will be given orally once a day (OD) at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg) and mebendazole will be given at dose of 100 mg orally twice a day (BD) daily
Follow-up Patients will be followed up with clinical events, CBC, LFT, KFT, INR, AFP, PIVKAII, CEMRI/ CECT upper abdomen (Triple phase ) at the end of 1 month, 3 months, 6 months, 9 months, 12 months and 15 months.
INVESTIGATIONS AND FOLLOW UP At Baseline (before therapy) and during follow up
- Hematology- repeated at the end of 1, 3, 6, 9, 12, 15 months.
- CBC
- Biochemistry - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- Serum Electrolytes, Kidney function test
- Liver function test, INR
- CTP and MELD scores
- AFP, PIVKA II - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- UGIE at baseline
- CEMRI / CECT upper abdomen - Triple phase - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- PET CT - if systemic spread suspected or else at the end of 6 and 15 months
- Liver Biopsy/FNAC will be done in cases where its clinically indicated.
The pre-clinical model will be developed in mice, for which separate application will be submitted to the animal ethics committee of the institute.
Timeline of follow up
- At the end of first month
- Then every 3 months until 15 months after starting therapy
STATISTICAL ANALYSIS
- Data will be reported as mean + SD
- Categorical variables will be compared using the chi-square test or Fisher exact test
- Normal continuous variables will be compared using the Student t test
- Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data).
- Comparison between groups on quantitative variables will be analyzed by ANOVA
- The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test
- A Cox regression analysis will be performed to identify independent prognostic factors for survival.
Intervention: This Randomized Controlled trial will be conducted at Institute of Liver \& Biliary SciencesLBS New Delhi between June 2020 and March 2022
Salvage therapy
- TACE or TARE if progressive disease
- Nivolilumab if the patient had a progressive disease at 6 months of therapy
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Being tested
- Lenvatinib, Mebendazole, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg
MebendazoleDrug
mebendazole will be given at dose of 100 mg orally twice a day (BD) daily
PlaceboOther
Placebo (Tab Mecovit) orally twice a day (BD) daily
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib +Placebo | Active comparator | Lenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg ) with placebo (Tab Mecovit) orally twice a day (BD) daily Receives: Drug: Lenvatinib; Other: Placebo |
| Lenvatinib and mebendazole | Experimental | Lenvatinib will be given orally once a day (OD) at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg) and mebendazole will be given at dose of 100 mg orally twice a day (BD) daily Receives: Drug: Lenvatinib; Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in both groups
Measured: 15 months
Death
Measured: 2 year
Progressive disease requiring change of therapy in both groups
Measured: 2 year
Secondary outcomes (4)
Progressive disease requiring quitting therapy in both groups
Measured: 2 year
Therapy related adverse effects in both groups
Measured: 2 year
Worsening of performance status in both groups
Worsening of performance will be measured by Eastern Cooperative Oncology Group (ECOG) Criteria.
Measured: 2 year
Decompensation of underlying cirrhosis in both groups
Barcelona-Clinic Liver Cancer (BCLC) staging classification will be used.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Jul 2020
- Primary completion19 Jun 2022 (estimated)
- Study completion19 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443049
- Sponsor's protocol ID
- ILBS-Cirrhosis-32
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT04443049
- Acronym / sponsor ID
- ILBS-Cirrhosis-32
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 19 Jun 2022 (estimated)
- Study completion
- 19 Jun 2022 (estimated)
- First posted
- 23 Jun 2020 (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.
Currently the available first line palliative therapy for advanced HCC is Sorafenib and Lenvatinib of which Lenvatinib is tolerated better. Unfortunately, patients tend to progress after few months of therapy. Therefore it is imperative, to do trials by combinative therapy to the available therapy for added survival benefits and quality of life with advanced HCC. In this regard, Mebendazole appears to be a good choice for drug repurposing as it has shown very promising results either alone or in combination with other therapies in tumors of GI origin and CNS tumors. With regard to HCC Mebendazole has been found to be effective in vitro system of HCC and preclinical models. However no clinical trials have been initiated till now. The key hallmark features of HCC include activation of MAPK and angiogenesis which in turn are targeted by RTK inhibitors such as Sorafenib and Lenvatinib. In this regard Mebendazole has broad range of action by not only inhibiting angiogenesis and pro-survival pathways of MAPK, but by also inhibiting the secretion of MMPs and Tubulin polymerization which can all be beneficial in tumor regression and prevention of chemo-resistance in HCC. Mounting of a strong immune response plays an important role in identification of tumor antigen and thereby clearing of tumors. While Mebendazole can modulate the tumor, the data is scant with respect to the role of the drug. Hence repurposing Mebendazole as a combinatorial therapy appears a promising approach and forms the basis of the present work. We hypothesize that combinatorial therapy of addition of mebendazole to lenvatinib will prove more beneficial than lenvatinib alone in increasing the overall survival of patients with advanced HCC. To prove the mechanistic effects of mebendazole on HCC, we will also conduct a animal study in preclinical mice model of HCC with the help of our animal house facility. The animal study will help us to understand the additional benefits from mebendazole and lenvatinib with objective evidence of liver biopsy which is not feasible in humans.
Detailed description
(A) STUDY HYPOTHESIS
- Mebendazole augments response of lenvatinib by synergistic response.
- Addition of anti angiogenic drugs (lenvatinib and mebendazole) to hypoxic environment generated post locoregional therapy like TACE leads to more effective control of advanced HCC resulting in improvement in overall survival. (B) AIM: To compare the efficacy of combination of mebendazole with lenvatinib in cirrhotics with advanced Hepatocellular Carcinoma. (C) OBJECTIVE:
Primary objective:
To compare the efficacy of combination of mebendazole with lenvatinib in improving the overall survival at 15 months in cirrhotics with advanced HCC.
Secondary objective:
- To compare the progression free survival with combination therapy of mebendazole and lenvatinib in advanced Hepatocellular Carcinoma (HCC).
- To compare the objective response rate (ORR), disease control rate (DCR) and clinical benefit rate (CBR) with combinative therapy of mebendazole and lenvatinib in advanced HCC.
- To study therapy related adverse effects of mebendazole in cirrhotics.
- To develop pre-clinical HCC animal model to prove the added efficacy of combination therapy. (D)STUDY DESIGN Type of study - Single center, prospective, open label, randomized control study Study population - cirrhosis of liver of any etiology with advanced HCC undergoing at ILBS Study duration - 22 months from the date of approval of IEC Sample size - Considering mebendazole adds 2 months more to lenvatinib which offers 13 months overall survival, power of the study as 80 %, attrition rate as 30 %, alpha error of 5%, sample size will be 85 patients in each arm ( totally 170 patients). (F) Methodology: Cirrhotics with advanced HCC proven by imaging and or biopsy or cytology, fulfilling the eligibility criteria will be enrolled in the study. They may undergo 1 or 2 sessions of locoregional therapy (TACE/ SBRT/RFA) if feasible. All patients will undergo complete physical examination, CBC, LFT, KFT, INR, AFP, PIVKAII, CEMRI/ CECT upper abdomen (Triple phase ), UGI endoscopy at baseline before randomization.
Randomization:
Those patients who are not feasible for locoregional therapy will be randomized at baseline. Those patients undergoing locoregional therapy will be randomized after 1 month of last locoregional therapy (patient may undergo maximum of two sessions of locoregional therapy before randomization). The response will be determined by m RECIST criteria before randomization. Those patients requiring further sessions of locoregional therapy beyond two sessions will not be randomized into study.
Patient will be then randomized to one of the two groups Arm I :Lenvatinib +Placebo( Lenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg ) with placebo (Tab Mecovit) orally twice a day (BD) daily Arm II : Lenvatinib and mebendazole ( Lenvatinib will be given orally once a day (OD) at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg) and mebendazole will be given at dose of 100 mg orally twice a day (BD) daily
Follow-up Patients will be followed up with clinical events, CBC, LFT, KFT, INR, AFP, PIVKAII, CEMRI/ CECT upper abdomen (Triple phase ) at the end of 1 month, 3 months, 6 months, 9 months, 12 months and 15 months.
INVESTIGATIONS AND FOLLOW UP At Baseline (before therapy) and during follow up
- Hematology- repeated at the end of 1, 3, 6, 9, 12, 15 months.
- CBC
- Biochemistry - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- Serum Electrolytes, Kidney function test
- Liver function test, INR
- CTP and MELD scores
- AFP, PIVKA II - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- UGIE at baseline
- CEMRI / CECT upper abdomen - Triple phase - repeated at the end of 1, 3, 6, 9, 12, 15 months.
- PET CT - if systemic spread suspected or else at the end of 6 and 15 months
- Liver Biopsy/FNAC will be done in cases where its clinically indicated.
The pre-clinical model will be developed in mice, for which separate application will be submitted to the animal ethics committee of the institute.
Timeline of follow up
- At the end of first month
- Then every 3 months until 15 months after starting therapy
STATISTICAL ANALYSIS
- Data will be reported as mean + SD
- Categorical variables will be compared using the chi-square test or Fisher exact test
- Normal continuous variables will be compared using the Student t test
- Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data).
- Comparison between groups on quantitative variables will be analyzed by ANOVA
- The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test
- A Cox regression analysis will be performed to identify independent prognostic factors for survival.
Intervention: This Randomized Controlled trial will be conducted at Institute of Liver \& Biliary SciencesLBS New Delhi between June 2020 and March 2022
Salvage therapy
- TACE or TARE if progressive disease
- Nivolilumab if the patient had a progressive disease at 6 months of therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib +Placebo | Active comparator | Drug: Lenvatinib, Other: PlaceboLenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg ) with placebo (Tab Mecovit) orally twice a day (BD) daily |
| Lenvatinib and mebendazole | Experimental | Drug: Lenvatinib, Drug: MebendazoleLenvatinib will be given orally once a day (OD) at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg) and mebendazole will be given at dose of 100 mg orally twice a day (BD) daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cirrhosis of Liver with HCC on imaging and/or biopsy or cytology
- Child Pugh A, Child Pugh B < 8
- Advanced HCC - as defined by BCLC - C
- ECOG Performance Status 1-2
- Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at screening and no change in antihypertensive therapy within 1 week prior to commencement of intervention.
Key exclusion criteria (7 listed)
- Decompensated Cirrhosis
- Child Pugh C, Child Pugh B > 7
- HCC patients with a curative therapy (RFA/MWA or LT)
- Prior systemic therapies (or) immunotherapy for HCC
- ECOG Performance Status 3-4
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 |
|---|---|---|
| LenvatinibLenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg | Drug | Lenvatinib +Placebo, Lenvatinib and mebendazole |
| Mebendazolemebendazole will be given at dose of 100 mg orally twice a day (BD) daily | Drug | Lenvatinib and mebendazole |
| PlaceboPlacebo (Tab Mecovit) orally twice a day (BD) daily | Other | Lenvatinib +Placebo |
Primary outcome
Overall survival in both groups
Time frame: 15 months
Death
Time frame: 2 year
Progressive disease requiring change of therapy in both groups
Time frame: 2 year
4 secondary outcomes
Progressive disease requiring quitting therapy in both groups
Time frame: 2 year
Therapy related adverse effects in both groups
Time frame: 2 year
Worsening of performance status in both groups
Time frame: 2 year
Decompensation of underlying cirrhosis in both groups
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenvatinib and Mebendazole in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Navin Kumar, MD (01146300000, navinktanvi10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival in both groups (time frame: 15 months). The study lists 3 primary outcomes in all. 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 5 Oct 2021.