Hepatocellular CarcinomaPhase 2NCT03851887
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
A Phase 2 study testing TAI combine SBRT in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the efiicacy of TAI combine SBRT in unresectable HCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TAI combine SBRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Jan 2022
- Phase
- Phase 2
- 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
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- cannot accepted hepatectomy;
- the lab test could meet:
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- neutrophil count≥2.0×109/L;
- hemoglobin≥100g/L;
- platelet count≥75×109/L;
- serum albumin≥35g/L;
- total bilirubin<2-times upper limit of normal;
- ALT<3-times upper limit of normal;
- AST<3-times upper limit of normal;
- serum creatine<1.5-times upper limit of normal;
- PT≤upper limit of normal plus 4 seconds;
- INR≤2.2;
- sign up consent.
Who cannot join
- cannot tolerate TAI or SBRT;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
- known history of HIV infection;
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- known history of drug or alcohol abuse;
- have GI hemorrhage or cardiac/brain vascular events within 30 days;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, 510060
Rong-Ping Guo, M.D., 00862087342266, guorp@sysucc.org.cn
Wei Wei, Ph.D. M.D., 00862087343790, weiwei@sysucc.org.cn
About this study
Official title: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
To evaluate the efiicacy of TAI combine SBRT in unresectable HCC
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TAI combine SBRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAI combine SBRTCombination product
TAI combine SBRT
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | TAI combine SBRT Receives: Combination Product: TAI combine SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: From date of randomization until the date of progression, assessed up to 36 months
ORR
objective response rate
Measured: From date of randomization until the date of death, assessed up to 36 months
Secondary outcomes (2)
OS
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
DCR
disease control rate
Measured: From date of randomization until the date of death, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Dec 2018
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2022 (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 Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-ping Guo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851887
- Sponsor's protocol ID
- B2019-002-01
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
- ClinicalTrials.gov ID
- NCT03851887
- Acronym / sponsor ID
- B2019-002-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 22 Feb 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 evaluate the efiicacy of TAI combine SBRT in unresectable HCC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Combination Product: TAI combine SBRTTAI combine SBRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- cannot accepted hepatectomy;
Key exclusion criteria (9 listed)
- cannot tolerate TAI or SBRT;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
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 |
|---|---|---|
| TAI combine SBRTTAI combine SBRT | Combination product | treatment group |
Primary outcome
PFS
Time frame: From date of randomization until the date of progression, assessed up to 36 months
progression-free survival
ORR
Time frame: From date of randomization until the date of death, assessed up to 36 months
objective response rate
2 secondary outcomes
OS
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
DCR
Time frame: From date of randomization until the date of death, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAI combine SBRT in people with Hepatocellular Carcinoma, run by Sun Yat-sen 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 17 inclusion and 9 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 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shaohua Li, MD (+8615088064187, lishaoh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of progression, assessed up to 36 months). 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?
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 Feb 2019.