Effect of an emerging treatment for liver cancer
| ISRCTN | ISRCTN12676151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12676151 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Beijing YouAn Hospital |
| Funder | You An Union Fund for liver disease and infectious disease |
- Submission date
- 29/06/2024
- Registration date
- 08/07/2024
- Last edited
- 05/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Transarterial chemoembolisation (TACE) is a cancer treatment where small particles are injected into the blood vessel that feeds the tumour to block off the blood supply. This study aimed to compare the effectiveness and safety of transarterial chemoembolization with CalliSpheres® drug-eluting beads loading with doxorubicin (DEB-TACE) versus conventional lipiodol (cTACE) in patients with unresectable hepatocellular carcinoma (HCC, a liver tumor that can't be removed with surgery).
Who can participate?
Patients aged 18-65 years with unresectable hepatocellular carcinoma (HCC)
What does the study involve?
Participants are randomly assigned to either the DEB-TACE group or the conventional lipiodol (cTACE) group. The DEB-TACE group received CalliSpheres® microspheres loaded with doxorubicin injected into the hepatic artery. The cTACE group received lipiodol combined with doxorubicin injected into the hepatic artery. All patients underwent baseline assessment, including clinical examination, laboratory tests, imaging studies, and liver function tests at the start of the study and after 3 and 12 months.
What are the possible benefits and risks of participating?
Tumor morphology on baseline imaging could inform decisions on the type of TACE that the individual patient would benefit from the most.
Where is the study run from?
Beijing Youan Hospital Capital Medical University (China)
When is the study starting and how long is it expected to run for?
January 2021 to December 2022
Who is funding the study?
You An Union Fund for liver disease and infectious disease (LM202005) (China)
Who is the main contact?
Guangming Li, ligm_light@163.com
Contact information
Public, Scientific, Principal investigator
No.8 You’anmenwai Xitoutiao
Beijing
100000
China
 ORCID ID |
0000-0002-2019-8363 |
|---|---|
| Phone | +86 (0)13466372671 |
| ligm_light@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of CalliSpheres® drug-loaded microspheres combined with doxorubicin in hepatocellular carcinoma |
| Study objectives | Tumor morphology on baseline imaging could inform decisions on the type of transarterial chemoembolization (TACE) that the individual patient would benefit from the most. Further studies are needed to confirm and elucidate these findings and to compare CalliSpheres® drug-eluting beads loading with doxorubicin (DEB-TACE) with other types of TACE. |
| Ethics approval(s) |
Approved 08/04/2021, Ethics Committee of Beijing Youan Hospital Capital Medical University (No.8 You’anmenwai Xitoutiao, Beijing, 100000, China; +86 (0)1083997028; bjyouanyiyuan@163.com), ref: LL-2021-035-K |
| Health condition(s) or problem(s) studied | Hepatocellular carcinoma (HCC) |
| Intervention | A total of 144 patients were randomly assigned to either the DEB-TACE group or the conventional lipiodol (cTACE) group using a computer-generated randomization sequence. The allocation ratio was 1:1. The patients, investigators, and outcome assessors were unaware of the group allocation. DEB-TACE group received CalliSpheres® microspheres (CSM) loaded with doxorubicin via a transarterial approach. The CSM were prepared by mixing poly lactic-co-glycolic acid (PLGA) microspheres with doxorubicin in a ratio of 1:10 in phosphate-buffered saline solution. The CSM were then injected into the hepatic artery under fluoroscopic guidance using a catheter system. The dose of doxorubicin was 20 mg per session, which was considered the maximum tolerated dose based on previous studies. cTACE group received lipiodol combined with doxorubicin via a transarterial approach. The lipiodol was prepared by mixing with doxorubicin of 20 mg per session and then injected into the hepatic artery under fluoroscopic guidance using a catheter system. All patients underwent baseline assessment, including clinical examination, laboratory tests, imaging studies, and liver function tests at baseline and after 3 months and 12 months follow-up. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CalliSpheres® drug-eluting beads loaded with doxorubicin (DEB-TACE) or conventional lipiodol (cTACE) |
| Primary outcome measure(s) | 1. Serum AFP level measured by enzyme-linked immunosorbent assay at baseline and after 3 months and 12 months follow-up 2. Tumor morphology measured using multidetector computed tomography (MDCT) or magnetic resonance imaging (MRI) evaluation at baseline and after 3 months and 12 months follow-up |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 144 |
| Key inclusion criteria | 1. Histologically confirmed diagnosis of HCC 2. No previous treatment for HCC 3. No contraindications for surgery, liver transplantation, or local ablation 4. No previous treatment with chemotherapy or targeted therapy for HCC 5. No history of radiation therapy for HCC 6. No history of radioembolization for HCC 7. No history of radiofrequency ablation for HCC 8. No history of percutaneous ethanol injection for HCC |
| Key exclusion criteria | Patients who had received any of the above treatments within 6 months before enrollment |
| Date of first enrolment | 09/04/2021 |
| Date of final enrolment | 01/06/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Guangming Li (ligm_light@163.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/07/2024: Study's existence confirmed by the Ethics Committee of Beijing Youan Hospital Capital Medical University.
