Advanced Hepatocellular Carcinoma (HCC)Phase 3NCT04523493
Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC
A Phase 3 study testing Toripalimab combined with Lenvatinib in people with Advanced Hepatocellular Carcinoma (HCC), run by Shanghai Junshi Bioscience Co., Ltd. at 22 sites in 5 countries.
Trial summary
This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- Toripalimab combined with Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 29 Jun 2020to 31 Mar 2027
- Phase
- Phase 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
- Age of 18-75 full years (inclusive), male or female.
- Histopathologically or cytologically confirmed HCC or participants with liver cirrhosis meet the clinical diagnostic criteria for HCC of the American Association for the Study of Liver Diseases (AASLD).
- Stage B (intermediate stage) or C (advanced stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage), be unsuitable for surgery and/or local therapy, or have progression of disease after surgery and/or local therapy.
- No previous use of any systemic therapy for HCC (mainly including systemic chemotherapy, antiangiogenic drugs or other molecular targeted therapy, immunotherapy containing CTLA-4, PD 1/PD-L1 monoclonal antibody).
- Having ≥ 1 measurable lesion in accordance with RECIST v1.1. Requirement: the selected target lesion has not been treated locally before, or is located in the area of previous local therapy and subsequently determined as PD through radiological examination and in accordance with RECIST v1.1.
- Child-Pugh class A or ≤7 class B, with no history of hepatic encephalopathy.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0-1.
- Expected survival ≥12 weeks.
- Main organ function meets the following requirements: no blood transfusion within 14 days prior to screening, no use of hematopoietic stimulating factor (including G-CSF, GM-CSF, EPO and TPO etc.) or human albumin preparation.
- In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be < 1000 IU/mL (if the lowest detectable value at the local center is higher than 1000IU/mL, enrollment can be determined based on the specific condition after discussed with sponsor), and it is required to continue original anti-HBV therapy in the full course, or start to use Entecavir or tenofovir in the full course after screening during the study.
- Female patients at childbearing age must receive serum pregnancy test within 7 days before randomization, have negative result, and are willing to use reliable and effective contraceptive methods during the trial and within 5 months after last administration. Male patients whose partners are women of childbearing potential must agree to use reliable and effective contraceptive methods during the trial and within 5 months after last administration.
- Being voluntary to participate in the study, sufficiently informed consent and sign the written informed consent form, with good compliance.
Who cannot join
- Known cholangiocellular carcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and hepatic fibrolamellar carcinoma.
- Malignant tumor except HCC within 5 years: however, localized tumor cured in the study is excluded,including cervical carcinoma in situ, skin basal cell carcinoma and carcinoma in situ of prostate.
- Hepatic surgery and/or local therapy or treatment with investigational product for HCC within 4 weeks prior to randomization; palliative radiation therapy for bone metastatic lesion within 2 weeks prior to randomization; use of Chinese medicine preparations with anti-liver cancer effect within two weeks prior to randomization. Toxicity induced by previous therapy (except alopecia) not recovered to ≤ grade 1 (NCI-CTCAE v5.0).
- Prior use of other anti-PD-1 antibody or other immunotherapy targeting PD-1/PD-L1.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate or severe peritoneal effusion at screening, defined as reaching the following criteria: having clinical symptoms and pleural and peritoneal effusion detected in physical examination at screening; or puncture for drainage required for pleural and peritoneal effusion and/or intracavitary administration during screening.
- History of gastrointestinal hemorrhage within 6 months prior to randomization or clear tendency of gastrointestinal hemorrhage (including severe esophageal-gastric varices with hemorrhagic risk, locally active peptic ulcer, persistent fecal occult blood (+)).
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- Having ≥ grade 3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula at present.
- Cancer thrombus invasion in the main trunk of portal vein (Vp4) (more than 1/2 of the lumen), inferior vena cava cancer thrombus or cardiac involvement in accordance with CT/MRI.
- Serious cardiovascular and cerebrovascular diseases:
- Other obvious hemorrhagic tendency or evidence on important coagulation disorder:
- Medium to large surgical treatment within 4 weeks prior to randomization, not including diagnostic biopsy.
- Know central nervous system metastasis; cranial and/or spinal MRI is needed for exclusion if central nervous system metastasis is suspected.
- Serious, uncured wound, active ulcer or untreated bone fracture.
- Vaccination of live vaccine within 30 days prior to randomization.
- Presence of immunodeficiency or receiving long-term systemic steroid therapy within 7 days prior to randomization (daily dose >10mg Prednisone or other equivalent glucocorticoid), or other immunosuppressive therapy.
- Active autoimmune diseases requiring systemic treatment (i.e., immunomodulatory drug, corticosteroid or immunosuppressant) in the past two years; however, replacement therapy (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency) will not be considered as systemic therapy and is allowed to be used.
- History of clear interstitial lung disease or non-infectious pneumonia, unless induced by local radiotherapy.
- Active tuberculosis or received antituberculosis therapy within 1 year prior to randomization.
- Any serious acute and chronic infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, not including viral hepatitis.
- Known history of human immunodeficiency virus (HIV) infection.
- Previously receiving allogeneic stem cell or solid organ transplantation.
- Inability to swallow tablets, malabsorption syndrome or any other condition that affects gastrointestinal absorption.
- Known history of serious allergy to any monoclonal antibody, anti-angiogenesis drug.
- Other participants who are unsuitable for inclusion as judged by the investigator."
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Ukraine8 sites
Communal Non-commercial Enterprise City Clinical Hospital #4 of Dnipro City Council, Department of Chemotherapy
Dnipro, 49102
Communal Non-profit Enterprise "Regional Center of Oncology", Department of Abdominal Organs Oncosurgery
Kharkiv, 61070
Communal Non-Profit Institution of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection of Population
Kharkiv, 61166
State Inst. O.O.Shalimov Nat. scientific certer of Surgery and Transplantology of Nat. Academy of Med.Sciences of Ukraine, Dep.of Oncology
Kyiv, 03126
Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, 43018
Communal Non-commercial Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of General Surgery
Odesa, 65025
Communal Non-commercial Enterprise of Sumy Regional Council, Sumy Regional Clinical Oncological Dispensar
Sumy, 40022
Communal Non-commercial Enterprise Zaporizhzhia Regional Antitumor Center of Zaporizhzhia Regional Council
Zaporizhzhya, 69040
Poland7 sites
Copernicus Podmiot Leczniczy sp. z o.o., Wojewodzkie Centrum Onkologii, Oddzial Onkologii Klinicznej/Chemioterapii
Gdansk, 80-219
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Oddzial Dzienny Chemioterapii
Koszalin, 75-581
PRATIA MCM Kraków, ul. Pana Tadeusza 2,
Krakow, 30-727
ID Clinic
Mysłowice, 41-400
Wielkopolskie Centrum Onkologii, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
Poznan, 61-866
Centrum Medyczne Pratia Poznań
Skórzewo, 60-185
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Klinika Onkologii i Radioterapii
Warsaw, 02-034
Italy5 sites
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico,Oncologia Medica
Milan, 20122
IRCCS Fondazione Giovanni Pascale, Istituto Nazionale Dei Tumori
Naples, 80131
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
A.O.U. Citta della Salute e della Scienza di Torino
Tortona
AOUI Verona - Policlinico "G.B. Rossi" di Borgo Roma
Verona, 37134
China1 site
Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
Nanjing, Jiangsu, 21000
About this study
Official title: A Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study to Compare Toripalimab Combined With Lenvatinib Versus Placebo Combined With Lenvatinib as the 1st-line Therapy for Advanced HCC
This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC.
Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- Toripalimab combined with Lenvatinib, Placebo combined with Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab combined with LenvatinibCombination product
Experimental group:
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
Placebo combined with LenvatinibCombination product
Control group:
Placebo, one unit, IV infusion, once every 3 weeks, combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Toripalimab combined with Lenvatinib Receives: Combination Product: Toripalimab combined with Lenvatinib |
| Control group | Placebo comparator | Placebo combined with Lenvatinib Receives: Combination Product: Placebo combined with Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from randomization to death for any reason.
Measured: Up to 3 years
Secondary outcomes (10)
ORR
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
Measured: Up to 3 years
Duration of Response (DOR)
Defined as the time from the first evaluation of CR or PR to the first evaluation of PD or death for any reason.
Measured: Up to 3 years
DCR
Defined as the proportion of subjects with the best overall response (BOR) of CR, PR or SD.
Measured: Up to 3 years
TTP
Defined as the time from randomization to objective tumor progression.
Measured: Up to 3 years
Progression-free survival (PFS)
The time from randomization to progression of disease or death for any reason, whichever comes first. Progression of disease will be evaluated
Measured: Up to 3 years
PFS rate
The PFS rate on 6 months and 1year in both groups.
Measured: Up to 3 years
OS rate
The OS rate on 1year and 2years in both groups.
Measured: Up to 3 years
Incidence,severity and prognosis of AEs/SAEs as assessed by NCI-CTCAE v5.0
Verbatim descriptions of adverse events will correspond to MedDRA synonymous terms, and AEs will be graded in accordance with NCI-CTCAE version 5.0. All the adverse events during or after the first dose of study drug will be summarized by treatment groups and NCI CTCAE grade. In addition, serious adverse events, adverse events (grade 3 or above) and the adverse events leading to discontinuation or suspension of study drug will be summarized correspondingly. Multiple occurrence of the same event will be counted once in accordance with the highest severity. The proportion of subjects with at least one adverse event will be reported by term of toxicity and treatment groups.
Measured: From date of consent informed until 90 days after the last investigational product administration. Up to 2 approximately years.
PK
According to the test of blood samples, the pharmacokinetic parameters of Toripalimab, mainly trough concentration, will be analyzed.
Measured: To be collected once within 60 minutes prior to administration each for Toripalimab/placebo on Day 1 of Cycle (each cycle is 21 days). but the no-china sites not collection the sample
Immunogenicity
Plasma level of anti-Toripalimab injection (JS001) antibody, immunoglobulin and Toripalimab injection (JS001) will be summarized descriptively.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 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
- NCT04523493
- Sponsor's protocol ID
- JS001-027-III-HCC
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study to Compare Toripalimab Combined With Lenvatinib Versus Placebo Combined With Lenvatinib as the 1st-line Therapy for Advanced HCC
- ClinicalTrials.gov ID
- NCT04523493
- Acronym / sponsor ID
- JS001-027-III-HCC
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Aug 2020 (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 is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC.
Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Toripalimab combined with LenvatinibToripalimab combined with Lenvatinib |
| Control group | Placebo comparator | Combination Product: Placebo combined with LenvatinibPlacebo combined with Lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age of 18-75 full years (inclusive), male or female.
- Histopathologically or cytologically confirmed HCC or participants with liver cirrhosis meet the clinical diagnostic criteria for HCC of the American Association for the Study of Liver Diseases (AASLD).
- Stage B (intermediate stage) or C (advanced stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage), be unsuitable for surgery and/or local therapy, or have progression of disease after surgery and/or local therapy.
- No previous use of any systemic therapy for HCC (mainly including systemic chemotherapy, antiangiogenic drugs or other molecular targeted therapy, immunotherapy containing CTLA-4, PD 1/PD-L1 monoclonal antibody).
- Having ≥ 1 measurable lesion in accordance with RECIST v1.1. Requirement: the selected target lesion has not been treated locally before, or is located in the area of previous local therapy and subsequently determined as PD through radiological examination and in accordance with RECIST v1.1.
Key exclusion criteria (24 listed)
- Known cholangiocellular carcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and hepatic fibrolamellar carcinoma.
- Malignant tumor except HCC within 5 years: however, localized tumor cured in the study is excluded,including cervical carcinoma in situ, skin basal cell carcinoma and carcinoma in situ of prostate.
- Hepatic surgery and/or local therapy or treatment with investigational product for HCC within 4 weeks prior to randomization; palliative radiation therapy for bone metastatic lesion within 2 weeks prior to randomization; use of Chinese medicine preparations with anti-liver cancer effect within two weeks prior to randomization. Toxicity induced by previous therapy (except alopecia) not recovered to ≤ grade 1 (NCI-CTCAE v5.0).
- Prior use of other anti-PD-1 antibody or other immunotherapy targeting PD-1/PD-L1.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate or severe peritoneal effusion at screening, defined as reaching the following criteria: having clinical symptoms and pleural and peritoneal effusion detected in physical examination at screening; or puncture for drainage required for pleural and peritoneal effusion and/or intracavitary administration during screening.
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 combined with LenvatinibExperimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol. | Combination product | Experimental group |
| Placebo combined with LenvatinibControl group: Placebo, one unit, IV infusion, once every 3 weeks, combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol. | Combination product | Control group |
Primary outcome
Overall survival (OS)
Time frame: Up to 3 years
The time from randomization to death for any reason.
10 secondary outcomes
ORR
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
DCR
Time frame: Up to 3 years
TTP
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
PFS rate
Time frame: Up to 3 years
OS rate
Time frame: Up to 3 years
Incidence,severity and prognosis of AEs/SAEs as assessed by NCI-CTCAE v5.0
Time frame: From date of consent informed until 90 days after the last investigational product administration. Up to 2 approximately years.
PK
Time frame: To be collected once within 60 minutes prior to administration each for Toripalimab/placebo on Day 1 of Cycle (each cycle is 21 days). but the no-china sites not collection the sample
Immunogenicity
Time frame: Up to 3 years
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 6 Jul 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.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab combined with Lenvatinib in people with Advanced Hepatocellular Carcinoma (HCC), run by Shanghai Junshi Bioscience Co., Ltd. at 22 sites in 5 countries.
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 12 inclusion and 24 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Ukraine, Poland, Italy, China, Singapore. 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 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?
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?
Overall survival (OS) (time frame: Up to 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 6 Jul 2026.