Hepatocellular CarcinomaNCT06836778
Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices
A study testing Carvedilol Tablets and Endoscopic Variceal Ligation in people with Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Carvedilol Tablets and Endoscopic Variceal Ligation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2025to 31 Jan 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Cirrhosis with HCC
- High risk oesophageal varices (*large or small with RCS)
- Valid consent
Who cannot join
- Any contra-indication to beta-blockers
- Any EVL or Sclerotherapy within last 3 months
- Any past history of TIPS or surgery for portal hypertension
- HCC with BCLC-D
- Patients with past history of variceal bleed.
- Patient With Liver transplant expected in next 2 weeks would be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Sarthak Chanana, MD, 01146300000, xs2sarthak@gmail.com
About this study
Official title: Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices: A Randomized Trial
Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis.
Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied.
The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.
Read the detailed description
Study population: All patients aged ≥ 18 years and ≤ 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.
Study design - Single center, Open label, Randomized controlled trial Study period - 6 months Intervention - The patients will be randomized into Group -A (NSBB arm) and Group-B (EVL + NSBB arm). Both the group will receive the remaining treatment as per protocol Group A: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) Group B: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months.
Monitoring and assessment: Monitoring and evaluation would be done once a month for first 3 months then at 6th month.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Carvedilol Tablets, Endoscopic Variceal Ligation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol TabletsDrug
Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55)
Endoscopic Variceal LigationProcedure or surgery
EVL every 3 weeks till eradication of varices followed by every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| NSBB+EVL | Experimental | Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months Receives: Drug: Carvedilol Tablets; Procedure: Endoscopic Variceal Ligation |
| NSBB | Active comparator | Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55) Receives: Drug: Carvedilol Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients of cirrhosis with HCC and high risk oesophageal varices on carvedilol developing variceal bleed with or without EVL in 6months follow up.
Measured: 6 months
Secondary outcomes (6)
Proportion of patient developing variceal bleed while on therapy with Tyrosine Kinase Inhibitors despite on carvedilol with or without EVL
Measured: 6 months
Proportion of patient developing variceal bleed while on therapy with immunotherapy despite on carvedilol with or without EVL.
Measured: 6 months
Percentage of patient of cirrhosis with HCC and Portal Vein Tumoral Thrombosis developing variceal bleed while on carvedilol with or without EVL.
Measured: 6 months
Proportion of patients having post-EVL ulcer bleed after endoscopic variceal ligation.
Measured: 6 months
Proportion of patients with change in non invasive test for portal hypertension in both groups.
Non invasive markers: LSM, SSM, APRI Score, ALBI Score
Measured: 6 months
Proportion of patient developing variceal bleed after SBRT for advanced Hepatocellular carcinoma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (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
- 100 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
- NCT06836778
- Sponsor's protocol ID
- ILBS-HCC-08
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 20 Feb 2025
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06836778
- Acronym / sponsor ID
- ILBS-HCC-08
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 20 Feb 2025 (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.
Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis.
Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied.
The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.
Detailed description
Study population: All patients aged ≥ 18 years and ≤ 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.
Study design - Single center, Open label, Randomized controlled trial Study period - 6 months Intervention - The patients will be randomized into Group -A (NSBB arm) and Group-B (EVL + NSBB arm). Both the group will receive the remaining treatment as per protocol Group A: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) Group B: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months.
Monitoring and assessment: Monitoring and evaluation would be done once a month for first 3 months then at 6th month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSBB+EVL | Experimental | Drug: Carvedilol Tablets, Procedure: Endoscopic Variceal LigationNon-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months |
| NSBB | Active comparator | Drug: Carvedilol TabletsNon-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Cirrhosis with HCC
- High risk oesophageal varices (*large or small with RCS)
- Valid consent
Key exclusion criteria (6 listed)
- Any contra-indication to beta-blockers
- Any EVL or Sclerotherapy within last 3 months
- Any past history of TIPS or surgery for portal hypertension
- HCC with BCLC-D
- Patients with past history of variceal bleed.
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 |
|---|---|---|
| Carvedilol TabletsNon-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP< 90 , H,R<55) | Drug | NSBB, NSBB+EVL |
| Endoscopic Variceal LigationEVL every 3 weeks till eradication of varices followed by every 3 months. | Procedure or surgery | NSBB+EVL |
Primary outcome
Proportion of patients of cirrhosis with HCC and high risk oesophageal varices on carvedilol developing variceal bleed with or without EVL in 6months follow up.
Time frame: 6 months
6 secondary outcomes
Proportion of patient developing variceal bleed while on therapy with Tyrosine Kinase Inhibitors despite on carvedilol with or without EVL
Time frame: 6 months
Proportion of patient developing variceal bleed while on therapy with immunotherapy despite on carvedilol with or without EVL.
Time frame: 6 months
Percentage of patient of cirrhosis with HCC and Portal Vein Tumoral Thrombosis developing variceal bleed while on carvedilol with or without EVL.
Time frame: 6 months
Proportion of patients having post-EVL ulcer bleed after endoscopic variceal ligation.
Time frame: 6 months
Proportion of patients with change in non invasive test for portal hypertension in both groups.
Time frame: 6 months
Proportion of patient developing variceal bleed after SBRT for advanced Hepatocellular carcinoma
Time frame: 6 months
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 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol Tablets and Endoscopic Variceal Ligation in people with Hepatocellular Carcinoma, 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Feb 2025. 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?
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 Dr Sarthak Chanana, MD (01146300000, xs2sarthak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients of cirrhosis with HCC and high risk oesophageal varices on carvedilol developing variceal bleed with or without EVL in 6months follow up. (time frame: 6 months). 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 20 Feb 2025.