Hepatocellular CarcinomaPhase 3NCT07691762
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
A Phase 3 study testing SHR-8068 + Adebrelimab + Bevacizumab in people with Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma. 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?
- SHR-8068 + Adebrelimab + Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 690 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Sep 2031
- 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 18-75 years old, male or female;
- Diagnosis confirmed HCC by pathologically or clinically;
- At least one measurable lesion;
- Child-Pugh liver function grade A;
- ECOG-PS score: 0 or 1;
- Eligible for TACE treatment as assessed by the investigator;
- Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
- Consent to contraception.
Who cannot join
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
- Participants with any active, known or suspected autoimmune disorder;
- Participants with hypertension which cannot be well controlled by antihypertensives;
- Uncontrolled cardiac diseases or symptoms;
- Participants with hepatic encephalopathy;
- Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment;
- History of gastrointestinal perforation and/or fistula;
- Participants with other potential factors that may affect the study results.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Gaojun Teng, +86-025-83272084, gjteng@seu.edu.cn
Gaojun Teng
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jia Fan, +86-021-64041990, fan.jia@zs-hospital.sh.cn
Jia Fan
About this study
Official title: A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.
Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SHR-8068 + Adebrelimab + Bevacizumab, SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo, SHR-8068 Placebo + Adebrelimab + Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068 + Adebrelimab + BevacizumabDrug
SHR-8068 + Adebrelimab + Bevacizumab, intravenous infusion, Transarterial Chemoembolization (TACE)
SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab PlaceboDrug
SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo, intravenous infusion, Transarterial Chemoembolization(TACE)
SHR-8068 Placebo + Adebrelimab + BevacizumabDrug
SHR-8068 Placebo + Adebrelimab + Bevacizumab, intravenous infusion, Transarterial Chemoembolization (TACE)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR-8068 + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE) Receives: Drug: SHR-8068 + Adebrelimab + Bevacizumab |
| Treatment group B | Active comparator | SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo + Transarterial Chemoembolization (TACE) Receives: Drug: SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo |
| Treatment group C | Experimental | SHR-8068 Placebo + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE) Receives: Drug: SHR-8068 Placebo + Adebrelimab + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by investigator
Measured: Until progression, assessed up to approximately 2 years.
Secondary outcomes (9)
Progression-free survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
Measured: Until progression, assessed up to approximately 2 years.
Overall survival (OS)
Measured: Until study completion, assessed up to approximately 2 years.
Objective response rate (ORR)
Measured: Until study completion, assessed up to approximately 2 years.
Disease control rate (DCR)
Measured: Until study completion, assessed up to approximately 2 years.
Duration of objective tumor response (DoR)
Measured: Until study completion, assessed up to approximately 2 years.
Adverse events (AEs)
Measured: Until study completion, assessed up to approximately 2 years.
Serious adverse events (SAEs)
Measured: Until study completion, assessed up to approximately 3 years.
Pharmacokinetics parameters of SHR-8068 and Adebrelimab: serum concentration
Measured: Approximately 90 days post-last dose.
Immunogenicity indicators of SHR-8068 and Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Measured: Approximately 90 days post-last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (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.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 690 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
- NCT07691762
- Sponsor's protocol ID
- SHR-8068-305
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07691762
- Acronym / sponsor ID
- SHR-8068-305
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 9 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 is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.
Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-8068 + Adebrelimab + BevacizumabSHR-8068 + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE) |
| Treatment group B | Active comparator | Drug: SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab PlaceboSHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo + Transarterial Chemoembolization (TACE) |
| Treatment group C | Experimental | Drug: SHR-8068 Placebo + Adebrelimab + BevacizumabSHR-8068 Placebo + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old, male or female;
- Diagnosis confirmed HCC by pathologically or clinically;
- At least one measurable lesion;
- Child-Pugh liver function grade A;
- ECOG-PS score: 0 or 1;
Key exclusion criteria (8 listed)
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
- Participants with any active, known or suspected autoimmune disorder;
- Participants with hypertension which cannot be well controlled by antihypertensives;
- Uncontrolled cardiac diseases or symptoms;
- Participants with hepatic encephalopathy;
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 + Adebrelimab + BevacizumabSHR-8068 + Adebrelimab + Bevacizumab, intravenous infusion, Transarterial Chemoembolization (TACE) | Drug | Treatment group A |
| SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab PlaceboSHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo, intravenous infusion, Transarterial Chemoembolization(TACE) | Drug | Treatment group B |
| SHR-8068 Placebo + Adebrelimab + BevacizumabSHR-8068 Placebo + Adebrelimab + Bevacizumab, intravenous infusion, Transarterial Chemoembolization (TACE) | Drug | Treatment group C |
Primary outcome
Progression-free survival (PFS) assessed by investigator
Time frame: Until progression, assessed up to approximately 2 years.
9 secondary outcomes
Progression-free survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
Time frame: Until progression, assessed up to approximately 2 years.
Overall survival (OS)
Time frame: Until study completion, assessed up to approximately 2 years.
Objective response rate (ORR)
Time frame: Until study completion, assessed up to approximately 2 years.
Disease control rate (DCR)
Time frame: Until study completion, assessed up to approximately 2 years.
Duration of objective tumor response (DoR)
Time frame: Until study completion, assessed up to approximately 2 years.
Adverse events (AEs)
Time frame: Until study completion, assessed up to approximately 2 years.
Serious adverse events (SAEs)
Time frame: Until study completion, assessed up to approximately 3 years.
Pharmacokinetics parameters of SHR-8068 and Adebrelimab: serum concentration
Time frame: Approximately 90 days post-last dose.
Immunogenicity indicators of SHR-8068 and Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Time frame: Approximately 90 days post-last dose.
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 29 Oct 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.
2 sites 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 + Bevacizumab in people with Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 8 inclusion and 8 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Junqin Yang (+86-0518-82342973, junqin.yang@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) assessed by investigator (time frame: Until progression, assessed up to approximately 2 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 29 Oct 2026.