Hepatocellular CarcinomaNCT03777475

the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

A study testing transarterial infusion in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

evaluate the effect of different oxaliplatin dose in TAI in treating 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?: transarterial infusion
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 1 siteChina
Study dates: 1 Jul 2016to 31 Dec 2022
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 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 hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
not previous treated for tumor;
unresectable;
the lab test could meet: 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 surgery;
known history of other malignancy;
be allergic to related drugs;
underwent organ transplantation before;
be treated before (interferon included);
known history of HIV infection;

Show all 9Show fewer

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

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
Recruiting

Other trials in China

About this study

evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Conditions: Hepatocellular Carcinoma
Being tested: transarterial infusion
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transarterial infusionProcedure or surgery
transarterial infusion

Study groups in NCT03777475
Study group	Role	What they receive
low dose	Experimental	low oxaliplatin (85mg/m2) Receives: Procedure: transarterial infusion
high dose	Active comparator	high oxaliplatin (135mg/m2) Receives: Procedure: transarterial infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

OS
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary outcomes (2)

ORR
object response rate
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
progression-free survival
Measured: From date of randomization until the date of progress from any cause, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201631 Dec 2022

First posted17 Dec 2018
Study start1 Jul 2016
Primary completion30 Jun 2021 (estimated)
Study completion31 Dec 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03777475
Sponsor's protocol ID: B2017-005-01
Status last verified: Dec 2018
First submitted: 12 Dec 2018
Last updated: 17 Dec 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT03777475
Acronym / sponsor ID: B2017-005-01
Conditions: Hepatocellular Carcinoma
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 350 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Jul 2016 (actual)
Primary completion: 30 Jun 2021 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 17 Dec 2018 (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.

evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
low dose	Experimental	Procedure: transarterial infusionlow oxaliplatin (85mg/m2)
high dose	Active comparator	Procedure: transarterial infusionhigh oxaliplatin (135mg/m2)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

older than 18 years old and younger than 75 years;
ECOG PS≤1;
proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
not previous treated for tumor;
unresectable;

Key exclusion criteria (9 listed)

cannot tolerate TAI or surgery;
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
transarterial infusiontransarterial infusion	Procedure or surgery	high dose, low dose

Primary outcome

OS
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival

2 secondary outcomes

ORR
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
Time frame: From date of randomization until the date of progress from any cause, assessed up to 60 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
Individual participant dataSharing planned: Undecided

Related trials for Hepatocellular Carcinoma

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.

SUN YAT-SEN University Cancer Center

Guangzhou, China

00862087342266

guorp@sysucc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transarterial infusion 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 7 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 17 Dec 2018. 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?

OS (time frame: From date of randomization until the date of death from any cause, assessed up to 60 months). 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 NCT03777475.

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 17 Dec 2018.