Hepatocellular CarcinomaPhase 2NCT03803254
HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC
A Phase 2 study testing Hepatic arterial infusion chemotherapy, Folfox Protocol and Lenvatinib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 3 sites 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 lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin… 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, Folfox Protocol and Lenvatinib
- 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
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jan 2019to 1 Jan 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
- 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.
- Barcelona clinic liver cancer-stage C
- 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:
- Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 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
3 sites in 1 country.
China3 sites
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, 510620
Kaiping Central Hospital
Kaiping, Guangdong, 529300
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Programmed Cell Death Protein-1 Antibody Versus Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib for Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)
Read the detailed description
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus lenvatinib and PD-1 antibody with HAIC plus lenvatinib. Thus, the investigators carried out this prospective randomized control study to find out it.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatic arterial infusion chemotherapy, Folfox Protocol, Lenvatinib, PD-1 antibody
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, Oxaliplatin, 5-Fluorouracil and Leucovorin, Hepatic arterial infusion chemotherapy
- 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
Folfox ProtocolDrug
Oxaliplatin , fluorouracil, and leucovorin
LenvatinibDrug
12 mg (or 8 mg) once daily (QD) oral dosing.
PD-1 antibodyDrug
3mg/kg intravenously every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| HAIC plus lenvatinib and PD-1 antibody | Experimental | Hepatic arterial infusion chemotherapy plus lenvatinib and programmed cell death protein-1 antibody Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Lenvatinib; Drug: PD-1 antibody |
| HAIC plus lenvatinib | Active comparator | Hepatic arterial infusion chemotherapy plus lenvatinib Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Measured: 12 months
Secondary outcomes (3)
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Measured: 12 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Measured: 12 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
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 posted14 Jan 2019
- Study start3 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: No participants enrolled
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
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
- Investigators
- Ming Shi, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803254
- Sponsor's protocol ID
- HCC-S058
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 6 May 2019
- 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 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Programmed Cell Death Protein-1 Antibody Versus Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03803254
- Acronym / sponsor ID
- HCC-S058
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, PD-1 Antibody, Oxaliplatin, 5-Fluorouracil and Leucovorin, Hepatic arterial infusion chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Kaiping Central Hospital, Guangzhou No.12 People's Hospital
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 14 Jan 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 lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)
Detailed description
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus lenvatinib and PD-1 antibody with HAIC plus lenvatinib. Thus, the investigators carried out this prospective randomized control study to find out it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC plus lenvatinib and PD-1 antibody | Experimental | Procedure: Hepatic arterial infusion chemotherapy, Drug: Folfox Protocol, Drug: Lenvatinib, Drug: PD-1 antibodyHepatic arterial infusion chemotherapy plus lenvatinib and programmed cell death protein-1 antibody |
| HAIC plus lenvatinib | Active comparator | Procedure: Hepatic arterial infusion chemotherapy, Drug: Folfox Protocol, Drug: LenvatinibHepatic arterial infusion chemotherapy plus lenvatinib |
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.
- Barcelona clinic liver cancer-stage C
- 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 | Procedure or surgery | HAIC plus lenvatinib, HAIC plus lenvatinib and PD-1 antibody |
| Folfox ProtocolOxaliplatin , fluorouracil, and leucovorin | Drug | HAIC plus lenvatinib, HAIC plus lenvatinib and PD-1 antibody |
| Lenvatinib12 mg (or 8 mg) once daily (QD) oral dosing. | Drug | HAIC plus lenvatinib, HAIC plus lenvatinib and PD-1 antibody |
| PD-1 antibody3mg/kg intravenously every 2 weeks | Drug | HAIC plus lenvatinib and PD-1 antibody |
Primary outcome
Overall Survival (OS)
Time frame: 12 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 12 months
Objective Response Rate (ORR)
Time frame: 12 months
Adverse Events
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 6 May 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.
Ming Shi, MD principal investigator
Sun Yat-sen University
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 Hepatic arterial infusion chemotherapy, Folfox Protocol and Lenvatinib 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 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: withdrawn, as of the sponsor's last update on 6 May 2019. 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?
Overall Survival (OS) (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 6 May 2019.