Hepatocellular CarcinomaNCT05017922
Efficacy of TACE With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma
A study testing transarterial chemoembolization combined with endoscopic therapy in people with Hepatocellular Carcinoma and Esophagogastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Esophagogastric Varices
- What is being tested?
- transarterial chemoembolization combined with endoscopic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 10 Aug 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. HCC was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in CNLC stage Ib to IIIa, and treated with TACE; 2. EGV was demonstrated through endoscopic examination; 3. Child-Pugh grade A or B, or grade C patients improved liver function to grade A or B through aggressive treatment; 4. age between 18 and 75 years.
Who cannot join
- 1. HCC with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices
The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival.
- Conditions
- Hepatocellular Carcinoma, Esophagogastric Varices
- Being tested
- transarterial chemoembolization combined with endoscopic therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transarterial chemoembolization combined with endoscopic therapyProcedure or surgery
TACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary.
| Study group | Role | What they receive |
|---|---|---|
| combined group | Experimental | unresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy Receives: Procedure: transarterial chemoembolization combined with endoscopic therapy |
| control group | Other | unresectable hepatocellular carcinoma patients who only received TACE Receives: Procedure: transarterial chemoembolization combined with endoscopic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of overall survival
Differences of overall survival between two groups
Measured: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Number of bleeding episodes
Differences of bleeding episodes between two groups
Measured: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017922
- Sponsor's protocol ID
- 2021719-Tao
- Status last verified
- Jul 2021
- First submitted
- 17 Aug 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tao Z, Ruan Y, Peng Z, Zhang K, Gao Y. Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices. Front Oncol. 2021 Dec 2;11:783574. doi: 10.3389/fonc.2021.783574. eCollection 2021.
PubMed 34926300
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TACE Combined With Endoscopic Therapy for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices
- ClinicalTrials.gov ID
- NCT05017922
- Acronym / sponsor ID
- 2021719-Tao
- Conditions
- Hepatocellular Carcinoma, Esophagogastric Varices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 24 Aug 2021 (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.
The study is aimed to explore the efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma (HCC) complicated with esophagogastric varices (EGV) and seek out predictors associated with survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined group | Experimental | Procedure: transarterial chemoembolization combined with endoscopic therapyunresectable hepatocellular carcinoma patients who received TACE plus endoscopic therapy |
| control group | Other | Procedure: transarterial chemoembolization combined with endoscopic therapyunresectable hepatocellular carcinoma patients who only received TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. HCC was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in CNLC stage Ib to IIIa, and treated with TACE; 2. EGV was demonstrated through endoscopic examination; 3. Child-Pugh grade A or B, or grade C patients improved liver function to grade A or B through aggressive treatment; 4. age between 18 and 75 years.
Key exclusion criteria (1 listed)
- 1. HCC with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.
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 |
|---|---|---|
| transarterial chemoembolization combined with endoscopic therapyTACE: The tip of the catheter was advanced into tumor-feeding artery based on the tumor location and size. 5-Fu was injected. Then the chemolipiodolization was performed, using oxaliplatin, epirubicin and lipiodol. If stagnant flow did not realized, then injected pure lipiodol. If the tumor-feeding artery still cannot be completely embolized, several absorbable gelatin sponge particles would be injected. Endoscopic therapy: After the site of esophageal varices was identified by the gastroscopy, spiral ligation using the EVL device (COOK, MBL-6-F) was performed and ensure the varices were fully inhaled, 1-3 rubber bands were used totally. After EVL, water was sprayed to the ligation sites to check for bleeding. If gastric varices were found, EIS was performed using the 'sandwich method' of hypertonic glucose-tissue adhesive-normal saline. Make sure the needle entered the varieose vein before inject drugs, and repeated the injection if necessary. | Procedure or surgery | combined group, control group |
Primary outcome
Time of overall survival
Time frame: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Differences of overall survival between two groups
Number of bleeding episodes
Time frame: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years
Differences of bleeding episodes between two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Derived from this study: PubMed 34926300Tao Z, Ruan Y, Peng Z, Zhang K, Gao Y. Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices. Front Oncol. 2021 Dec 2;11:783574. doi: 10.3389/fonc.2021.783574. eCollection 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transarterial chemoembolization combined with endoscopic therapy in people with Hepatocellular Carcinoma and Esophagogastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of overall survival (time frame: In July 2020 or the day of death or the day of lost to follow-up or follow-up for 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017922, which also lists 1 linked publication.
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 28 Oct 2021.