Carcinoma, HepatocellularPhase 4NCT02631499
Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
A Phase 4 study testing TACE, Epirubicin and lipiodol in people with Carcinoma, Hepatocellular and Neoplastic Cells, Circulating, run by Fudan University at 6 sites in China.
Trial summary
This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Neoplastic Cells, Circulating
- What is being tested?
- TACE, Epirubicin and lipiodol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 6 sitesChina
- Study dates
- Dec 2015to Dec 2019
- Phase
- Phase 4
- 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
- HCC patients received curative hepatectomy with negative resection margin
- Age from 18 to 75
- Child-Pugh class A
- ASA class I to II
- ECOG performance status Grade 0 or 1
- Preoperative CTC level ≥2 per 7.5 ml peripheral blood
- No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy
Who cannot join
- Patients diagnosed with other types of malignancies besides HCC
- Patients receiving concomitant local ablation or previous TACE
- Main portal vein tumor thrombus extraction during hepatectomy
- Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
- Presence of extra-hepatic or lymphatic metastasis
- Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
Show all 13Show fewer
- Renal impairment with creatinine > 200micromol/L
- Severe concurrent medical illness persisting > 6 weeks after hepatectomy
- History of other cancer
- Hepatic artery anomaly making TACE not possible
- Allergy to 5-Fluorouracil, Epirubicin or lipiodol
- Pregnant woman
- Informed consent not available
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Nantong Tumor Hospital
Nantong, Jiangsu, 226000
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200000
Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200000
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.
- Being tested
- TACE, Epirubicin, lipiodol
- Keywords
- Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplastic Cells, Circulating, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called Transcatheter Arterial Chemoembolization, Chemoembolization
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
EpirubicinDrug
Also called EADM
Epirubicin is a chemotherapy drug used in TACE
lipiodolDrug
Also called Ultra-fluid lipiodol
lipiodol is a kind of embolization material used in TACE
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant TACE | Experimental | TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE. Receives: Procedure: TACE; Drug: Epirubicin; Drug: lipiodol |
| Control | No intervention | no interventions were assigned after hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early recurrence rates
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
Measured: 1 year after hepatectomy
Secondary outcomes (1)
Overall Survival
OS was defined as the interval from date of HCC resection to death due to any cause.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Fudan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Johnson & Johnson Medical, China
- Responsible party
- Principal investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, MD & PhD, Principal investigator, Shanghai Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631499
- Sponsor's protocol ID
- CTC-HE-TACE
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4.
PubMed 23175471Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.
PubMed 19408012Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791.
PubMed 15334671
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
- ClinicalTrials.gov ID
- NCT02631499
- Acronym / sponsor ID
- CTC-HE-TACE
- Keywords
- Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Johnson & Johnson Medical, China
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- 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 study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.
Detailed description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant TACE | Experimental | Procedure: TACE, Drug: Epirubicin, Drug: lipiodolTACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE. |
| Control | No intervention | –no interventions were assigned after hepatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HCC patients received curative hepatectomy with negative resection margin
- Age from 18 to 75
- Child-Pugh class A
- ASA class I to II
- ECOG performance status Grade 0 or 1
Key exclusion criteria (13 listed)
- Patients diagnosed with other types of malignancies besides HCC
- Patients receiving concomitant local ablation or previous TACE
- Main portal vein tumor thrombus extraction during hepatectomy
- Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
- Presence of extra-hepatic or lymphatic metastasis
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 |
|---|---|---|
| TACEAlso: Transcatheter Arterial Chemoembolization, ChemoembolizationTACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE. | Procedure or surgery | Adjuvant TACE |
| EpirubicinAlso: EADMEpirubicin is a chemotherapy drug used in TACE | Drug | Adjuvant TACE |
| lipiodolAlso: Ultra-fluid lipiodollipiodol is a kind of embolization material used in TACE | Drug | Adjuvant TACE |
Primary outcome
Early recurrence rates
Time frame: 1 year after hepatectomy
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
1 secondary outcome
Overall Survival
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Background: PubMed 23175471Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4.
- Background: PubMed 19408012Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.
- Background: PubMed 15334671Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791.
- Individual participant dataSharing planned: Undecided
Related trials for Carcinoma, Hepatocellular
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.
Jia Fan, MD & PhD principal investigator
Shanghai Zhongshan Hospital, Fudan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TACE, Epirubicin and lipiodol in people with Carcinoma, Hepatocellular and Neoplastic Cells, Circulating, run by Fudan University at 6 sites 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 7 inclusion and 13 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xin-Rong Yang, MD & PhD (008618616881978, yang.xinrong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early recurrence rates (time frame: 1 year after hepatectomy). 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 NCT02631499, which also lists 3 linked publications.
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 22 Dec 2015.