Hepatocellular CarcinomaPhase 2/3JUPITER 04NCT03859128
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
A Phase 2/3 study testing TORIPALIMAB INJECTION(JS001 ) in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour. 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?
- TORIPALIMAB INJECTION(JS001 )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2019to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
- BICR confirmed no resdual tumor lesions are detected in liver;
- Child-Puch score, Class A;
- ECOG score is 0;
Who cannot join
- Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
- Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
- With symptoms of central nervous system metastasis;
- With any history of active autoimmune disease or autoimmune disease;
- Known liver diseases with clinical significance;
- Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TORIPALIMAB INJECTION(JS001 )
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORIPALIMAB INJECTION(JS001 )Biological
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | TORIPALIMAB 240mg ,Q3W, up to 16 cycles Receives: Biological: TORIPALIMAB INJECTION(JS001 ) |
| Group B | Placebo comparator | Placebo 240mg Q3W, up to 16 cycles Receives: Biological: TORIPALIMAB INJECTION(JS001 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BICR-RFS
Defined as the time from randomization to the first documented disease recurrence or death.
Measured: Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)
Secondary outcomes (8)
Investigator-RFS
the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first
Measured: up to 100 months
12-month recurrence-free survival rate (RFS12)
probability of patients without recurrence or death for any cause at Month 12
Measured: up to 100 months
24-month recurrence-free survival rate (RFS24)
probability of patients without recurrence or death for any cause at Month 24
Measured: up to 100 months
Time to recurrence (TTR)
the time from randomization to the first documented disease recurrence
Measured: up to 44 months
Time to local recurrence (TTLR)
the time from randomization to the first documented local disease recurrence
Measured: up to 44 months
Overall survival (OS)
the time from randomization to death for any cause
Measured: up to 44 months
12- and 24-month overall survival rate (OS12 and OS24)
probability of patients surviving at Month 12 and 24, respectively
Measured: up to 44 months
Incidence of AEs
Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0
Measured: up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start5 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859128
- Sponsor's protocol ID
- JS001-016-III-HCC
- Acronym
- JUPITER 04
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2019
- Last updated
- 10 Aug 2026
- Results posted
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
- ClinicalTrials.gov ID
- NCT03859128
- Acronym / sponsor ID
- JUPITER 04 / JS001-016-III-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Mar 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.
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.
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 |
|---|---|---|
| Group A | Active comparator | Biological: TORIPALIMAB INJECTION(JS001 )TORIPALIMAB 240mg ,Q3W, up to 16 cycles |
| Group B | Placebo comparator | Biological: TORIPALIMAB INJECTION(JS001 )Placebo 240mg Q3W, up to 16 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
- BICR confirmed no resdual tumor lesions are detected in liver;
- Child-Puch score, Class A;
- ECOG score is 0;
Key exclusion criteria (7 listed)
- Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
- Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
- With symptoms of central nervous system metastasis;
- With any history of active autoimmune disease or autoimmune disease;
- Known liver diseases with clinical significance;
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 |
|---|---|---|
| TORIPALIMAB INJECTION(JS001 )Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W | Biological | Group A, Group B |
Primary outcome
BICR-RFS
Time frame: Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)
Defined as the time from randomization to the first documented disease recurrence or death.
8 secondary outcomes
Investigator-RFS
Time frame: up to 100 months
12-month recurrence-free survival rate (RFS12)
Time frame: up to 100 months
24-month recurrence-free survival rate (RFS24)
Time frame: up to 100 months
Time to recurrence (TTR)
Time frame: up to 44 months
Time to local recurrence (TTLR)
Time frame: up to 44 months
Overall survival (OS)
Time frame: up to 44 months
12- and 24-month overall survival rate (OS12 and OS24)
Time frame: up to 44 months
Incidence of AEs
Time frame: up to 44 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TORIPALIMAB INJECTION(JS001 ) in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
BICR-RFS (time frame: Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)). 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 Aug 2026.