Hepatocellular CarcinomaPhase 3NCT04687163
Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial
A Phase 3 study testing HAIC of 130 mg/m² Oxaliplatin, and 5-fu, HAIC of 85 mg/m² Oxaliplatin, and 5-fu and TKI in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 3 sites in China.
Trial summary
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. 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?
- HAIC of 130 mg/m² Oxaliplatin, and 5-fu, HAIC of 85 mg/m² Oxaliplatin, and 5-fu and TKI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 30 Dec 2020to 1 Dec 2022
- Phase
- Phase 3
- 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
- KPS≥70;
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- Patients must have at least one tumor lesion that can be accurately measured;
- With vascular invasion or extrahepatic metastasis
- Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
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- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
- ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
- ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
- Ability to understand the protocol and to agree to and sign a written informed consent document.
Who cannot join
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Shi, MD, 8620-87343115, shiming@mail.sysu.edu.cn
- Recruiting
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, 510620
Yuanmin Zhou, MD, 15521278919, 13430288977@139.com
YuanMin Zhou, MD
- Recruiting
Kaiping Central Hospital
Kaiping, Guangdong, 529300
Shijie Zhang, MD, 13717287622, Shijie_9262511@163.com
About this study
Official title: Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 130 mg/m² Oxaliplatin, Leucovorin, and Fluorouracil Versus Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 85 mg/m² Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Advanced Hepatocellular Carcinoma: a Randomised Phase 3 Trial
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC of 130 mg/m² Oxaliplatin, and 5-fu, HAIC of 85 mg/m² Oxaliplatin, and 5-fu, TKI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC of 130 mg/m² Oxaliplatin, and 5-fuDrug
Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
HAIC of 85 mg/m² Oxaliplatin, and 5-fuDrug
Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
TKIDrug
sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight <60 kg)
| Study group | Role | What they receive |
|---|---|---|
| OXA 130 | Experimental | Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu Receives: Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fu; Drug: TKI |
| OXA 85 | Active comparator | Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu Receives: Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fu; Drug: TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 24 months
Secondary outcomes (4)
progression-free survival
Measured: 24 months
objective response rate
Measured: 6 months
time to response
time to the date that patients achieved objective response
Measured: 12 months
Adverse Events
Measured: 30 Days after HAIC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start30 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiping Central Hospital, Guangzhou No.12 People's Hospital
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687163
- Sponsor's protocol ID
- SH-3
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 130 mg/m² Oxaliplatin, Leucovorin, and Fluorouracil Versus Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 85 mg/m² Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Advanced Hepatocellular Carcinoma: a Randomised Phase 3 Trial
- ClinicalTrials.gov ID
- NCT04687163
- Acronym / sponsor ID
- SH-3
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Kaiping Central Hospital, Guangzhou No.12 People's Hospital
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Dec 2020 (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.
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OXA 130 | Experimental | Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fu, Drug: TKIPatients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu |
| OXA 85 | Active comparator | Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fu, Drug: TKIPatients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- KPS≥70;
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- Patients must have at least one tumor lesion that can be accurately measured;
- With vascular invasion or extrahepatic metastasis
- Diagnosed as unresectable with consensus by the panel of liver surgery experts;
Key exclusion criteria (8 listed)
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
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 |
|---|---|---|
| HAIC of 130 mg/m² Oxaliplatin, and 5-fuHepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU | Drug | OXA 130 |
| HAIC of 85 mg/m² Oxaliplatin, and 5-fuHepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU | Drug | OXA 85 |
| TKIsorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight <60 kg) | Drug | OXA 130, OXA 85 |
Primary outcome
Overall survival
Time frame: 24 months
4 secondary outcomes
progression-free survival
Time frame: 24 months
objective response rate
Time frame: 6 months
time to response
Time frame: 12 months
Adverse Events
Time frame: 30 Days after HAIC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HAIC of 130 mg/m² Oxaliplatin, and 5-fu, HAIC of 85 mg/m² Oxaliplatin, and 5-fu and TKI in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 3 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 11 inclusion and 8 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Overall survival (time frame: 24 months). 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 13 Jan 2021.