Hepatocellular CarcinomaPhase 2NCT03722498
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
A Phase 2 study testing HAIC of FOLFOX and Sorafenib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 3 sites in China.
Trial summary
To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE) 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 FOLFOX and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2018to 22 Mar 2021
- 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
- TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
- Except for TACE, patients have received no previous anti-tumor treatment;
- The diagnosis of HCC was based on histological results;
- Patients must have at least one tumor lesion that can be accurately measured;
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
- No Cirrhosis or cirrhotic status of Child-Pugh class A only;
- No liver protection therapy in 2 weeks before enrolled, and 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 ≤ 5 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
- 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;
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
- 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
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, 510620
Ming Shi
Guangzhou, Guangdong
Kaiping Central Hospital
Kaiping, Guangdong, 529300
About this study
Official title: Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)
Read the detailed description
In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.
Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC of FOLFOX, Sorafenib
- Keywords
- Hepatic arterial infusion chemotherapy, Sorafenib
- 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 FOLFOXDrug
Also called Oxaliplatin , fluorouracil, and leucovorin
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
SorafenibDrug
administration of Sorafenib
| Study group | Role | What they receive |
|---|---|---|
| HAIC of FOLFOX | Experimental | Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil Receives: Drug: HAIC of FOLFOX |
| Sorafenib | Active comparator | Sorafenib 400 mg orally twice a day Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Measured: 12 months
Secondary outcomes (3)
Overall survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Measured: 12 months
Adverse Events
Postoperative adverse events were graded based on CTCAE v4.03
Measured: 30 Days after HAIC and TACE
Objective response rate
Best response based on mRECIST
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Jun 2018
- Primary completion22 Mar 2021 (estimated)
- Study completion22 Mar 2021 (estimated)
Why it stopped: No patients join
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou No.12 People's Hospital, Kaiping Central Hospital
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
- Investigators
- Ming Shi, MD, Principal investigator, The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722498
- Sponsor's protocol ID
- HCC-H171011
- Status last verified
- Jul 2023
- First submitted
- 25 Oct 2018
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization
- ClinicalTrials.gov ID
- NCT03722498
- Acronym / sponsor ID
- HCC-H171011
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatic arterial infusion chemotherapy, Sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients join
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou No.12 People's Hospital, Kaiping Central Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 22 Mar 2021 (estimated)
- Study completion
- 22 Mar 2021 (estimated)
- First posted
- 29 Oct 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.
To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)
Detailed description
In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.
Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC of FOLFOX | Experimental | Drug: HAIC of FOLFOXHepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil |
| Sorafenib | Active comparator | Drug: SorafenibSorafenib 400 mg orally twice a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
- Except for TACE, patients have received no previous anti-tumor treatment;
- The diagnosis of HCC was based on histological results;
- Patients must have at least one tumor lesion that can be accurately measured;
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
Key exclusion criteria (6 listed)
- 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;
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
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 FOLFOXAlso: Oxaliplatin , fluorouracil, and leucovorinadministration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries | Drug | HAIC of FOLFOX |
| Sorafenibadministration of Sorafenib | Drug | Sorafenib |
Primary outcome
Progression-free survival
Time frame: 12 months
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
3 secondary outcomes
Overall survival
Time frame: 12 months
Adverse Events
Time frame: 30 Days after HAIC and TACE
Objective response rate
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ming Shi, MD principal investigator
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAIC of FOLFOX and Sorafenib 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 11 Jul 2023. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 12 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 11 Jul 2023.