Tumor Response RateNCT03910140
TILA-TACE in Treatment of Hepatocellular Carcinoma
A study testing TILA-TACE treatment in people with Tumor Response Rate and Overall Survival, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tumor Response Rate, Overall Survival
- What is being tested?
- TILA-TACE treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard;
- ECOG score 0-1;
- HCC BCLC grading 0, A, B, C;
- Child-Pugh score prior to therapy A and B;
- As judged by investigators, the patient can comply with the study protocol;
- Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form.
Who cannot join
- HCC BCLC grading D;
- Child-Pugh score prior to therapy C.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Min Chao, +86 13957139239, z2doctor_chaoming@163.com
About this study
Official title: A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma
To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.
- Conditions
- Tumor Response Rate, Overall Survival
- Being tested
- TILA-TACE treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TILA-TACE treatmentProcedure or surgery
Also called 3D-CRT, SBRT, SIRT
TACE was performed through the transfemoral route using a 5-Fr catheter (Shepherd-hook modified Angiographic Catheter, HANACO Medical, Tian Jin, China ) that was advanced from celiac artery to common hepatic artery, proper hepatic artery, hepatic artery and ultimately to tumor feeding arteries which are defined by angiography. Then, a coaxial microcatheter (2.8 Fr Marguerite II, ASAHI INTECC GMA CO., LTD, Nagoya, Japan) was selectively inserted through a 5-Fr catheter into the tumor feeding artery, into which, 5% sodium bicarbonate was infused alternatively with doxorubicin-lipiodol emulsion. Finally, the artery was embolized with PVA (Embosphere®, BioSphere Medical, Paris, France) and microcoil ( Tornado ®, COOK Medical, USA).
| Study group | Role | What they receive |
|---|---|---|
| TILA-TACE group | Experimental | Not described Receives: Procedure: TILA-TACE treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response to treatment
Viable tumors were assessed by MRI according to EASL criteria. The enhanced and non-enhanced areas represent viable and necrotic tumors. At least 2 radiologists evaluate the approximate viable tumor residues (%) of total tumor volume (Total tumor volume was the sum of viable and necrotic volume).
The response to treatment is defined by the Viable Tumor Residues (%) as below: complete response (CR), no obvious viable residuals; near complete response (NCR), viable residuals <10%; partial response (PR), viable residuals >10% but < 50%; stable disease (SD), viable tumor residuals between >50% but ≤100%; and progressive disease (PD), viable tumors > 100%.
Measured: 1 month after therapy
Secondary outcomes (1)
Lifetime (months)
Record the survival time of patients by follow up visits.
Measured: 6 months once after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Nov 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Response RateStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910140
- Sponsor's protocol ID
- ZUSAHZUCI201701
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share data for several times in experiment; Research Manager: http://www.medresman.org/login.aspx
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03910140
- Acronym / sponsor ID
- ZUSAHZUCI201701
- Conditions
- Tumor Response Rate, Overall Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Apr 2019 (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.
To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TILA-TACE group | Experimental | Procedure: TILA-TACE treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard;
- ECOG score 0-1;
- HCC BCLC grading 0, A, B, C;
- Child-Pugh score prior to therapy A and B;
- As judged by investigators, the patient can comply with the study protocol;
Key exclusion criteria (2 listed)
- HCC BCLC grading D;
- Child-Pugh score prior to therapy C.
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 |
|---|---|---|
| TILA-TACE treatmentAlso: 3D-CRT, SBRT, SIRTTACE was performed through the transfemoral route using a 5-Fr catheter (Shepherd-hook modified Angiographic Catheter, HANACO Medical, Tian Jin, China ) that was advanced from celiac artery to common hepatic artery, proper hepatic artery, hepatic artery and ultimately to tumor feeding arteries which are defined by angiography. Then, a coaxial microcatheter (2.8 Fr Marguerite II, ASAHI INTECC GMA CO., LTD, Nagoya, Japan) was selectively inserted through a 5-Fr catheter into the tumor feeding artery, into which, 5% sodium bicarbonate was infused alternatively with doxorubicin-lipiodol emulsion. Finally, the artery was embolized with PVA (Embosphere®, BioSphere Medical, Paris, France) and microcoil ( Tornado ®, COOK Medical, USA). | Procedure or surgery | TILA-TACE group |
Primary outcome
The response to treatment
Time frame: 1 month after therapy
Viable tumors were assessed by MRI according to EASL criteria. The enhanced and non-enhanced areas represent viable and necrotic tumors. At least 2 radiologists evaluate the approximate viable tumor residues (%) of total tumor volume (Total tumor volume was the sum of viable and necrotic volume). The response to treatment is defined by the Viable Tumor Residues (%) as below: complete response (CR), no obvious viable residuals; near complete response (NCR), viable residuals <10%; partial response (PR), viable residuals >10% but < 50%; stable disease (SD), viable tumor residuals between >50% but ≤100%; and progressive disease (PD), viable tumors > 100%.
1 secondary outcome
Lifetime (months)
Time frame: 6 months once after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Undecided. share data for several times in experiment; Research Manager: http://www.medresman.org/login.aspx
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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 Second affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TILA-TACE treatment in people with Tumor Response Rate and Overall Survival, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 2 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 10 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response to treatment (time frame: 1 month after therapy). 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 2019.