Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence RiskPhase 2NCT07682272
A Trial of SHR-8068 Combined With Adebrelimab and Apatinib in Perioperative Treatment of Resectable Hepatocellular Carcinoma
A Phase 2 study testing SHR-8068 Injection, Adebrelimab Injection and Apatinib Mesylate Tablets in people with Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
- What is being tested?
- SHR-8068 Injection, Adebrelimab Injection and Apatinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Jul 2029
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participate in this study and sign the informed consent form.
- Age from 18 to 70, male or female.
- Histopathologically/cytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).
- At least one measurable lesion based on RECIST v1.1.
- No prior systemic antitumor therapy for HCC.
- ECOG Performance Status (PS) score of 0-1.
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- Child-Pugh liver function class A.
- Expected survival at least 3 months.
- Adequate organ function.
- Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
Who cannot join
- Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- Other malignancies within the past 5 years or concurrent malignancy.
- Known history of severe hypersensitivity reaction to any monoclonal antibody.
- Previous or current central nervous system metastases.
- Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage.
- Hypertension that cannot be well controlled with antihypertensive medication.
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- Poorly controlled cardiac symptoms or heart disease.
- Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency.
- Arterial thrombotic or embolic events within 6 months before enrollment.
- Any other condition that, in the investigator's judgment, may affect the study results or lead to premature termination of the study.
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
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Jian Zhou, +86-021-64041990, zhou.jian@zs-hospital.sh.cn
Jian Zhou
About this study
Official title: A Randomized, Open-label, Multicenter Phase II Study of SHR-8068 Combined With Adebrelimab and Apatinib for Perioperative Treatment in Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
- Being tested
- SHR-8068 Injection, Adebrelimab Injection, Apatinib Mesylate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068 InjectionDrug
SHR-8068 injection.
Adebrelimab InjectionDrug
Adebrelimab injection.
Apatinib Mesylate TabletsDrug
Apatinib mesylate tablets.
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068 + Adebrelimab + Apatinib Group | Experimental | SHR-8068, Adebrelimab, Apatinib. Receives: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets |
| Adebrelimab + Apatinib Group | Active comparator | Adebrelimab, Apatinib. Receives: Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR (70%)) rate.
MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed.
Measured: After surgery, approximately 3 months.
Secondary outcomes (5)
Event-free survival (EFS).
Measured: From randomization to event, approximately 2 years.
12-month and 24-month Event-free survival (EFS) rate.
Measured: From randomization to event, approximately 2 years.
R0 resection rate.
Measured: After surgery, approximately 3 months.
Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.
Measured: Approximately 2 years.
Safety endpoints, including surgical complications by Clavien-Dindo.
Measured: Approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence RiskStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07682272
- Sponsor's protocol ID
- SHR-8068-208
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase II Study of SHR-8068 Combined With Adebrelimab and Apatinib for Perioperative Treatment in Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
- ClinicalTrials.gov ID
- NCT07682272
- Acronym / sponsor ID
- SHR-8068-208
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 2 Jul 2026 (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 is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.
| Arm | Type | Receives |
|---|---|---|
| SHR-8068 + Adebrelimab + Apatinib Group | Experimental | Drug: SHR-8068 Injection, Drug: Adebrelimab Injection, Drug: Apatinib Mesylate TabletsSHR-8068, Adebrelimab, Apatinib. |
| Adebrelimab + Apatinib Group | Active comparator | Drug: Adebrelimab Injection, Drug: Apatinib Mesylate TabletsAdebrelimab, Apatinib. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who voluntarily participate in this study and sign the informed consent form.
- Age from 18 to 70, male or female.
- Histopathologically/cytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).
- At least one measurable lesion based on RECIST v1.1.
- No prior systemic antitumor therapy for HCC.
Key exclusion criteria (10 listed)
- Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- Other malignancies within the past 5 years or concurrent malignancy.
- Known history of severe hypersensitivity reaction to any monoclonal antibody.
- Previous or current central nervous system metastases.
- Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage.
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-8068 InjectionSHR-8068 injection. | Drug | SHR-8068 + Adebrelimab + Apatinib Group |
| Adebrelimab InjectionAdebrelimab injection. | Drug | Adebrelimab + Apatinib Group, SHR-8068 + Adebrelimab + Apatinib Group |
| Apatinib Mesylate TabletsApatinib mesylate tablets. | Drug | Adebrelimab + Apatinib Group, SHR-8068 + Adebrelimab + Apatinib Group |
Primary outcome
Major pathological response (MPR (70%)) rate.
Time frame: After surgery, approximately 3 months.
MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed.
5 secondary outcomes
Event-free survival (EFS).
Time frame: From randomization to event, approximately 2 years.
12-month and 24-month Event-free survival (EFS) rate.
Time frame: From randomization to event, approximately 2 years.
R0 resection rate.
Time frame: After surgery, approximately 3 months.
Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.
Time frame: Approximately 2 years.
Safety endpoints, including surgical complications by Clavien-Dindo.
Time frame: Approximately 2 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 2 Jul 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 2 study testing SHR-8068 Injection, Adebrelimab Injection and Apatinib Mesylate Tablets in people with Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk, 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 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 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 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?
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?
Major pathological response (MPR (70%)) rate. (time frame: After surgery, approximately 3 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 2 Jul 2026.