Advanced Hepatocellular CarcinomaPhase 3NCT03605706
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With FOLFOX4 in Subjects With Advanced HCC Who Have Never Received Prior Systemic Treatment.
A Phase 3 study testing SHR-1210 and FOLFOX4 in people with Advanced Hepatocellular Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- SHR-1210 and FOLFOX4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2019to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.1. ECOG Performance Status of 0 or 1. Child-Pugh Class A or B with 7 points. Life Expectancy of at least 12 weeks. HBV DNA<500 IU/ml. Adequate organ function： Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
Who cannot join
- Known fibrolamellar HCC, Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
- Known or occurrence of central nervous system (CNS) metastases. Ascites with clinical symptoms. Known or evidence of GI hemorrhage within the past 6 months. Known or occurrence of hemorrhage/ thrombus. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
- Grade III~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 150mmHg, diastolic blood pressure > 90 mmHg).
- History of hepatic encephalopathy. Known history of human immunodeficiency virus (HIV) infection. Active infection or an unexplained fever > 38.5°C during screening visits. Prior or planning to organ transplantation including liver transplantation. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Proteinuria≥ 2+ and 24 hours total urine protein > 1.0 g. Active known, or suspected autoimmune disease. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
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- Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
- Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
- Pregnant or breast-feeding women. According to the investigator, other conditions that may lead to stop the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
81 Hospital Nanjing
Nanjing, Jiangsu, 210002
Shukui Qin, MD, +862580864542
About this study
Official title: A Phase III, Multicentered, Randomized, Double-blinded, Parallel Controlled Study to Evaluate Camrelizumab (PD-1 Antibody) in Combination With FOLFOX4 Regimen Versus Placebo in Combination With FOLFOX4 Regime in First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC).
The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4.
The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- SHR-1210, FOLFOX4, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
FOLFOX4Drug
Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks
PlaceboDrug
Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 | Experimental | SHR-1210+FOLFOX4 Receives: Drug: SHR-1210; Drug: FOLFOX4 |
| CONTROL | Experimental | SHR-1210+Placebo Receives: Drug: FOLFOX4; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS was defined as the time from randomization to death due to any cause
Measured: Up to approximately 3 years
Secondary outcomes (7)
Objective Response Rate (ORR) per RECIST 1.1 in all participants
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Measured: Up to approximately 6 months
Time to Progression (TTP) per RECIST 1.1 in all participants
Measured: Up to approximately 3 years
Duration of Response (DoR) per RECIST 1.1 in all participants
Measured: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1 in all participants
Measured: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST 1.1 in all participants
Measured: Up to approximately 3 years
AE
Measured: Up to approximately 3 years
Overall Survival (OS) rate at 9 months and 12 months
Measured: Up to approximately 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start31 May 2019
- Primary completionFeb 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qing, MD, Study chair, China, Jiangsu 81 Hospital Nanjing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605706
- Sponsor's protocol ID
- SHR-1210-III-305-HCC
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2018
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentered, Randomized, Double-blinded, Parallel Controlled Study to Evaluate Camrelizumab (PD-1 Antibody) in Combination With FOLFOX4 Regimen Versus Placebo in Combination With FOLFOX4 Regime in First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC).
- ClinicalTrials.gov ID
- NCT03605706
- Acronym / sponsor ID
- SHR-1210-III-305-HCC
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Jul 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4.
The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.
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 |
|---|---|---|
| SHR-1210 | Experimental | Drug: SHR-1210, Drug: FOLFOX4SHR-1210+FOLFOX4 |
| CONTROL | Experimental | Drug: FOLFOX4, Drug: PlaceboSHR-1210+Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has not received prior systemic treatment for their advanced/metastatic HCC. Has measurable disease according to RECIST v1.1. ECOG Performance Status of 0 or 1. Child-Pugh Class A or B with 7 points. Life Expectancy of at least 12 weeks. HBV DNA<500 IU/ml. Adequate organ function： Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
Key exclusion criteria (9 listed)
- Known fibrolamellar HCC, Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
- Known or occurrence of central nervous system (CNS) metastases. Ascites with clinical symptoms. Known or evidence of GI hemorrhage within the past 6 months. Known or occurrence of hemorrhage/ thrombus. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
- Grade III~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 150mmHg, diastolic blood pressure > 90 mmHg).
- History of hepatic encephalopathy. Known history of human immunodeficiency virus (HIV) infection. Active infection or an unexplained fever > 38.5°C during screening visits. Prior or planning to organ transplantation including liver transplantation. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
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 |
|---|---|---|
| SHR-1210Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks | Drug | SHR-1210 |
| FOLFOX4Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks | Drug | CONTROL, SHR-1210 |
| PlaceboSubjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks | Drug | CONTROL |
Primary outcome
Overall Survival
Time frame: Up to approximately 3 years
OS was defined as the time from randomization to death due to any cause
7 secondary outcomes
Objective Response Rate (ORR) per RECIST 1.1 in all participants
Time frame: Up to approximately 6 months
Time to Progression (TTP) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Duration of Response (DoR) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
AE
Time frame: Up to approximately 3 years
Overall Survival (OS) rate at 9 months and 12 months
Time frame: Up to approximately 9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Shukui Qing, MD study chair
China, Jiangsu 81 Hospital Nanjing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1210 and FOLFOX4 in people with Advanced Hepatocellular Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. 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 1 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 10 Feb 2022. 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 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?
Contact Linna Wang, MD (021-60453196, wanglinna@hrglobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to approximately 3 years). 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 10 Feb 2022.