Hepatocellular CarcinomaPhase 2NCT04135690
HAIC Plus Toripalimab vs. HAIC Plus Sorafenib for HCC With PVTT: a Non-comparative, Prospective, Randomized Trial
A Phase 2 study testing Hepatic arterial infusion chemotherapy, Toripalimab and Sorafenib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with 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?
- Hepatic arterial infusion chemotherapy, Toripalimab and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2019to 20 Dec 2023
- 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
- 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 according to EASL criteria.
- Patients with portal vein tumor thrombus
- Eastern Cooperative Oncology Group performance status of 0 to 2
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
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- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- The following laboratory parameters:
- Platelet ≥75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits 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
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known central nervous system tumors including metastatic brain disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Shi, MD, 8620-87343115, shiming@mail.sysu.edu.cn
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Plus Toripalimab Versus Hepatic Arterial Infusion Chemotherapy Plus Sorafenib for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Non-comparative, Prospective, Randomized Trial
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.
Read the detailed description
Our previous study showed that hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. Programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus toripalimab with HAIC plus sorafenib. Thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatic arterial infusion chemotherapy, Toripalimab, Sorafenib, systemic treatment
- Keywords
- Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Oxaliplatin, 5-Fluorouracil and Leucovorin, Toripalimab, 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.
Hepatic arterial infusion chemotherapyProcedure or surgery
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
ToripalimabDrug
240mg intravenously every 3 weeks
SorafenibDrug
400mg bid po
systemic treatmentDrug
atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on
| Study group | Role | What they receive |
|---|---|---|
| HAIC plus toripalimab | Experimental | Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Toripalimab 240mg intravenously every 3 weeks. Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Toripalimab |
| HAIC plus sorafenib | Active comparator | Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Sorafenib 400mg twice daily (Bid) oral dosing. Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Sorafenib |
| Patients receiving TKI plus ICI | Other | Patients, who meet the inclusion criteria but withdraw consent or reject this study, receive systemic treatment according to the doctor. Systemic treatment include atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on. Receives: Drug: systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate at 6 months
Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause
Measured: 6 months
Secondary outcomes (4)
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Measured: 6 months
Progression free survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
Measured: 6 months
Objective response rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Measured: 6 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start20 Oct 2019
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135690
- Sponsor's protocol ID
- S0905
- Status last verified
- Aug 2023
- First submitted
- 20 Oct 2019
- Last updated
- 15 Aug 2023
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Plus Toripalimab Versus Hepatic Arterial Infusion Chemotherapy Plus Sorafenib for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Non-comparative, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT04135690
- Acronym / sponsor ID
- S0905
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Oxaliplatin, 5-Fluorouracil and Leucovorin, Toripalimab, Sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 23 Oct 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.
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.
Detailed description
Our previous study showed that hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. Programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus toripalimab with HAIC plus sorafenib. Thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HAIC plus toripalimab | Experimental | Procedure: Hepatic arterial infusion chemotherapy, Drug: ToripalimabHepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Toripalimab 240mg intravenously every 3 weeks. |
| HAIC plus sorafenib | Active comparator | Procedure: Hepatic arterial infusion chemotherapy, Drug: SorafenibHepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Sorafenib 400mg twice daily (Bid) oral dosing. |
| Patients receiving TKI plus ICI | Other | Drug: systemic treatmentPatients, who meet the inclusion criteria but withdraw consent or reject this study, receive systemic treatment according to the doctor. Systemic treatment include atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 according to EASL criteria.
- Patients with portal vein tumor thrombus
- Eastern Cooperative Oncology Group performance status of 0 to 2
- With no previous treatment
Key exclusion criteria (8 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 |
|---|---|---|
| Hepatic arterial infusion chemotherapyadministration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks | Procedure or surgery | HAIC plus sorafenib, HAIC plus toripalimab |
| Toripalimab240mg intravenously every 3 weeks | Drug | HAIC plus toripalimab |
| Sorafenib400mg bid po | Drug | HAIC plus sorafenib |
| systemic treatmentatezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on | Drug | Patients receiving TKI plus ICI |
Primary outcome
Progression free survival rate at 6 months
Time frame: 6 months
Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause
4 secondary outcomes
Overall survival (OS)
Time frame: 6 months
Progression free survival (PFS)
Time frame: 6 months
Objective response rate (ORR)
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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 Hepatic arterial infusion chemotherapy, Toripalimab and Sorafenib 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 10 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 15 Aug 2023. 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 Ming Shi, MD (+862087343938, shiming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate at 6 months (time frame: 6 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 15 Aug 2023.