Hepatocellular CarcinomaPhase 3TACE-EBRTNCT03116984
A Study of Comparison of TACE Combination With and Without EBRT for Advanced HCC
A Phase 3 study testing Transcatheter arterial chemoembolization and External- beam radiotherapy in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transcatheter arterial chemoembolization and External- beam radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria 1）initially diagnosed HCC (confirmed by pathology or meet clinical diagnostic criteria), 2）The patients are not candidates for curative surgery, which should be determined in consultation with two oncology surgeons of the same center, 3）Tumor was confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3, 4）Child-Pugh A，white blood cell count >2*109/L、Hb>90g/L、PLT>50*109/L, 5）The score of Eastern Cooperative Oncology Group(ECOG): 0-2, 6）The estimated survival time > 3 months, 7）Without midsection history of radiation therapy, 8）Age: >18 years old, 9）Informed consent was signed.
- Exclusion Criteria 1）Diffuse hepatocellular carcinoma, 2）Uncontrollable infection, 3）Concurrent other malignant tumors, 4）Simultaneously participate in other experimental drugs or clinical trials, 5）Serious of heart, lung and kidney diseases, 6）During pregnancy and lactation, 7) The ones with severe neurologic morbidity couldn't clearly tell therapeutic response.
- Halfway exit criteria 1）Do not treat according to the research or seriously violate the fundamental principles after enrolled, 2）Cannot tolerate radiation therapy, including the ones that cann't complete the radiation treatment( the dose <40 Gy,biological effective dose <48 Gy), or interrupt more than 2 weeks during radiotherapy, 3）Unwilling to continue this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Yixing Chen, Phd, 86-13916056575, chen.yixing@zs-hospital.sh.cn
Zhaochong Zeng, Professor
About this study
Official title: A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for HCC Which is Unresectable But Confined to the Liver
This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the follow-up period. The study design plans to enroll 300 patients, and each group includes 150 cases.
Read the detailed description
Enrolled HCC patients met the inclusion criterion, in the late or advanced stage,tumor confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3. Eligible participants will be randomly assigned to the group A by TACE and the other group B by EBRT after 2 times TACE.
TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE.
EBRT group: Patients who were randomized to the radiotherapy group start radiotherapy 3-5 weeks after the completion 2 times TACE and began to undergo radiation. Radiotherapy equipment is based on the conditions of the cooperative units. 3-dimensional conformal radiation therapy(3-DCRT), intensity-modulated radiation therapy(IMRT) or Image-Guided Radiotherapy(IGRT) will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or Volumetric Modulated Arc Therapy(VMAT). The target volume should include the visible tumor.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transcatheter arterial chemoembolization, External- beam radiotherapy
- Keywords
- Hepatocellular Carcinoma, external- beam radiotherapy (EBRT), transarterial chemoembolization (TACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial chemoembolizationProcedure or surgery
Also called TACE
Transcatheter arterial chemoembolization (TACE) is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol was determined by diameter and blood supply type of HCC, generally 5-20ml, and no more than 30ml once.
External- beam radiotherapyRadiation
Also called EBRT
We have reported a series of retrospective clinical trials in which transarterial chemoembolization (TACE) combined with external- beam radiotherapy (EBRT) was a better treatment method than TACE alone for unresectable HCC in the same period and organization, no matter in aspects of the regression rate of carcinoma or survival.Patients who were randomized to the EBRT 3-5 weeks after the completion 2 times TACE.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter arterial chemoembolization | Active comparator | TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE treatment.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of ultra fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE. Receives: Procedure: Transcatheter arterial chemoembolization |
| External-beam radiotherapy | Experimental | EBRT group: Patients who were randomized to the external- beam radiotherapy (EBRT) 3-5 weeks after the completion 2 times TACE.Radiotherapy equipment is based on the conditions of the cooperative units. 3-DCRT, IMRT or IGRT will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or VMAT. The target volume should include the visible tumor. Receives: Radiation: External- beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival(OS)
The therapeutic effects are mainly evaluated by the 3-year overall survival(OS).
Measured: The outcome measures are assessed up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Jan 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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 Shanghai Zhongshan HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, First Affiliated Hospital of Zhejiang University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fujian Cancer Hospital, First Affiliated Hospital of Fujian Medical University, Zhongshan Hospital Xiamen University, West China Hospital, Peking University Cancer Hospital & Institute, Xinqiao Hospital of Chongqing, 309th Hospital of Chinese People's Liberation Army, Heilongjiang Provincial Agricultural Reclamation General Hospital, Longyan City First Hospital, Peking University First Hospital, The Third Affiliated Hospital of Qiqihar Medical Universitiy, Anhui Provincial Hospital, First Affiliated Hospital of Xinjiang Medical University, Qingdao University, The 4th people's hospital of Wuxi City, Affiliated to Jiangnan University, Subei People's Hospital of Jiangsu Province,Yangzhou University, Affiliated Zhongshan Hospital of Dalian University, Jilin University, First Affiliated Hospital of Guangxi Medical University, Fudan University, Shanghai East Hospital of Tongji University, Chinese PLA General Hospital, The 4th People's Hospital of Linfen City, Nanfang Hospital, Southern Medical University, Yunnan Cancer Hospital, Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, First Affiliated Hospital, Sun Yat-Sen University, The Second Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The People's Hospital of Hunan Province
- Responsible party
- Principal investigator, Zeng Zhaochong, Shanghai Zhongshan Hospital
- Investigators
- Zhongshan Hospital, Study director, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116984
- Sponsor's protocol ID
- ZS-TACE-EBRT-2017
- Other IDs
- 2016ZSLC20
- Acronym
- TACE-EBRT
- Status last verified
- Apr 2020
- First submitted
- 1 Mar 2017
- Last updated
- 10 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for HCC Which is Unresectable But Confined to the Liver
- ClinicalTrials.gov ID
- NCT03116984
- Acronym / sponsor ID
- TACE-EBRT / ZS-TACE-EBRT-2017
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, external- beam radiotherapy (EBRT), transarterial chemoembolization (TACE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, First Affiliated Hospital of Zhejiang University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fujian Cancer Hospital, First Affiliated Hospital of Fujian Medical University, Zhongshan Hospital Xiamen University, West China Hospital, Peking University Cancer Hospital & Institute, Xinqiao Hospital of Chongqing, 309th Hospital of Chinese People's Liberation Army, Heilongjiang Provincial Agricultural Reclamation General Hospital, Longyan City First Hospital, Peking University First Hospital, The Third Affiliated Hospital of Qiqihar Medical Universitiy, Anhui Provincial Hospital, First Affiliated Hospital of Xinjiang Medical University, Qingdao University, The 4th people's hospital of Wuxi City, Affiliated to Jiangnan University, Subei People's Hospital of Jiangsu Province,Yangzhou University, Affiliated Zhongshan Hospital of Dalian University, Jilin University, First Affiliated Hospital of Guangxi Medical University, Fudan University, Shanghai East Hospital of Tongji University, Chinese PLA General Hospital, The 4th People's Hospital of Linfen City, Nanfang Hospital, Southern Medical University, Yunnan Cancer Hospital, Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, First Affiliated Hospital, Sun Yat-Sen University, The Second Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The People's Hospital of Hunan Province
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Apr 2017 (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.
This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the follow-up period. The study design plans to enroll 300 patients, and each group includes 150 cases.
Detailed description
Enrolled HCC patients met the inclusion criterion, in the late or advanced stage,tumor confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3. Eligible participants will be randomly assigned to the group A by TACE and the other group B by EBRT after 2 times TACE.
TACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE.
EBRT group: Patients who were randomized to the radiotherapy group start radiotherapy 3-5 weeks after the completion 2 times TACE and began to undergo radiation. Radiotherapy equipment is based on the conditions of the cooperative units. 3-dimensional conformal radiation therapy(3-DCRT), intensity-modulated radiation therapy(IMRT) or Image-Guided Radiotherapy(IGRT) will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or Volumetric Modulated Arc Therapy(VMAT). The target volume should include the visible tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter arterial chemoembolization | Active comparator | Procedure: Transcatheter arterial chemoembolizationTACE group: The frequency of treatment is determined based on the disease condition for patients who are randomly assigned to group of TACE treatment.TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of ultra fluid lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor achieves a complete response after two times TACE. |
| External-beam radiotherapy | Experimental | Radiation: External- beam radiotherapyEBRT group: Patients who were randomized to the external- beam radiotherapy (EBRT) 3-5 weeks after the completion 2 times TACE.Radiotherapy equipment is based on the conditions of the cooperative units. 3-DCRT, IMRT or IGRT will be opted based on hospital. IGRT can also be used via helical tomotherapy, Rapid Arc or VMAT. The target volume should include the visible tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Transcatheter arterial chemoembolizationAlso: TACETranscatheter arterial chemoembolization (TACE) is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol was determined by diameter and blood supply type of HCC, generally 5-20ml, and no more than 30ml once. | Procedure or surgery | Transcatheter arterial chemoembolization |
| External- beam radiotherapyAlso: EBRTWe have reported a series of retrospective clinical trials in which transarterial chemoembolization (TACE) combined with external- beam radiotherapy (EBRT) was a better treatment method than TACE alone for unresectable HCC in the same period and organization, no matter in aspects of the regression rate of carcinoma or survival.Patients who were randomized to the EBRT 3-5 weeks after the completion 2 times TACE. | Radiation | External-beam radiotherapy |
Primary outcome
3-year overall survival(OS)
Time frame: The outcome measures are assessed up to three years.
The therapeutic effects are mainly evaluated by the 3-year overall survival(OS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Zhongshan Hospital study director
Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcatheter arterial chemoembolization and External- beam radiotherapy in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital 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?
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 10 Apr 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaochong Zeng, Phd (13817076800, zeng.zhaochong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival(OS) (time frame: The outcome measures are assessed up to three years.). 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 10 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.