Advanced Hepatocellular CarcinomaPhase 3NCT06618664
A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
A Phase 3 study testing SHR-8068, Adebrelimab and Bevacizumab in people with Advanced Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02). 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-8068, Adebrelimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2024to Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent.
- ≥ 18 years old, both male and female.
- Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
- At least one measurable lesion based on RECIST v1.1 criteria.
- Barcelona clinic liver cancer: Stage B or C.
- No previous systemic antitumor therapy for HCC.
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- ECOG PS of 0-1.
- Child-Pugh score of A or B7.
- Expected survival period ≥ 12 weeks.
- Adequate organ function.
- Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
Who cannot join
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
- Patients with other malignancies currently or within the past 5 years.
- With known severe allergic reactions to any other monoclonal antibodies.
- Patients with known CNS metastasis or hepatic encephalopathy.
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
- Patients with symptomatic ascites or pleural effusion.
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- Patients with hypertension which cannot be well controlled by antihypertensives.
- Uncontrolled cardiac diseases or symptoms.
- Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
- Major vascular disease occurred in the 6 months before randomization.
- Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
- Major surgery within 28 days before randomization or expected to require major surgery during the study period.
- Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
- Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- Patients with other potential factors that may affect the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Lianxin Liu, +86-13845159888, liulx@ustc.edu.cn
Shukui Qin, +86-13905158713, qinsk@csco.org.cn
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- SHR-8068, Adebrelimab, Bevacizumab, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068Drug
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
AdebrelimabDrug
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
BevacizumabDrug
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
SintilimabDrug
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068 combined with Adebrelimab and Bevacizumab | Experimental | Not described Receives: Drug: SHR-8068; Drug: Adebrelimab; Drug: Bevacizumab |
| Sintilimab combined with Bevacizumab | Active comparator | Not described Receives: Drug: Bevacizumab; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Overall survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
Secondary outcomes (6)
Time to Progression (TTP)
TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.
Measured: From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.
Measured: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.
Measured: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
Duration of Response (DoR)
DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first).
Measured: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
Time to Response (TTR)
TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.
Measured: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0
Measured: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start28 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2030 (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 Suzhou Suncadia Biopharmaceuticals 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
- Model description
- The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618664
- Sponsor's protocol ID
- SHR-8068-301
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)
- ClinicalTrials.gov ID
- NCT06618664
- Acronym / sponsor ID
- SHR-8068-301
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Oct 2024 (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 aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.
| Arm | Type | Receives |
|---|---|---|
| SHR-8068 combined with Adebrelimab and Bevacizumab | Experimental | Drug: SHR-8068, Drug: Adebrelimab, Drug: Bevacizumab |
| Sintilimab combined with Bevacizumab | Active comparator | Drug: Bevacizumab, Drug: Sintilimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able and willing to provide a written informed consent.
- ≥ 18 years old, both male and female.
- Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
- At least one measurable lesion based on RECIST v1.1 criteria.
- Barcelona clinic liver cancer: Stage B or C.
Key exclusion criteria (16 listed)
- Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
- Patients with other malignancies currently or within the past 5 years.
- With known severe allergic reactions to any other monoclonal antibodies.
- Patients with known CNS metastasis or hepatic encephalopathy.
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
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-8068SHR-8068: injection, 50 mg/10 mL, intravenous infusion | Drug | SHR-8068 combined with Adebrelimab and Bevacizumab |
| AdebrelimabAdebrelimab: injection, 600 mg/12 mL, intravenous infusion | Drug | SHR-8068 combined with Adebrelimab and Bevacizumab |
| BevacizumabBevacizumab: injection, 100 mg/4 mL, intravenous infusion | Drug | SHR-8068 combined with Adebrelimab and Bevacizumab, Sintilimab combined with Bevacizumab |
| SintilimabSintilimab: injection, 100 mg/10 mL, intravenous infusion | Drug | Sintilimab combined with Bevacizumab |
Primary outcome
Progression Free Survival (PFS)
Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Overall survival (OS)
Time frame: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
OS is defined as the time from randomization to death from any cause.
6 secondary outcomes
Time to Progression (TTP)
Time frame: From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
Disease Control Rate (DCR)
Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Objective Response Rate (ORR)
Time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
Duration of Response (DoR)
Time frame: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
Time to Response (TTR)
Time frame: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0
Time frame: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 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 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
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-8068, Adebrelimab and Bevacizumab in people with Advanced Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals 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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Sep 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. 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?
Contact Xin Shi (+86-0518-82342973, xin.shi.xs3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)). The study lists 2 primary outcomes in all. 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 25 Sep 2026.