Hepatocellular CarcinomaPhase 3NCT07813572
ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular
A Phase 3 study testing ZG005 for Injection, Bevacizumab ( Avastin) and Sintilimab in people with Hepatocellular Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ZG005 for Injection, Bevacizumab ( Avastin) and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2032
- 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
- Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
- At least one measurable lesion based on Recist1.1.
- No prior systemic therapy for HCC.
- Child-Pugh ≤6 , no history of hepatic encephalopathy.
Who cannot join
- Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
- Any condition that is not suitable for participate in this study as determined by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ZG005 for Injection, Bevacizumab ( Avastin), Sintilimab, 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.
ZG005 for InjectionDrug
Also called ZG005
Participants receive ZG005 20 mg/kg IV, Q3W
Bevacizumab ( Avastin)Drug
Participants receive Bevacizumab ( Avastin) 15 mg/kg IV, Q3W
SintilimabDrug
Participants receive Sintilimab 200mg IV, Q3W
BevacizumabDrug
Also called 达攸同
Participants receive Bevacizumab 15 mg/kg IV, Q3W
| Study group | Role | What they receive |
|---|---|---|
| ZG005+Bevacizumab | Experimental | ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W Receives: Drug: ZG005 for Injection; Drug: Bevacizumab ( Avastin) |
| Sintilimab Plus Bevacizumab | Active comparator | Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W Receives: Drug: Sintilimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1
Measured: up to 3 years
Overall survival (OS)
Measured: up to 5 years
Secondary outcomes (2)
PFS
PFS evaluated by investigator based on RECIST V1.1
Measured: up to 3 years
Objective response rate (ORR)
ORR evaluated by IRC based on RECIST V1.1
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 posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2032 (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 Zelgen Biopharmaceuticals Co.,LtdThe 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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study director, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813572
- Sponsor's protocol ID
- ZG005-011
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07813572
- Acronym / sponsor ID
- ZG005-011
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 10 Sep 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.
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZG005+Bevacizumab | Experimental | Drug: ZG005 for Injection, Drug: Bevacizumab ( Avastin)ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W |
| Sintilimab Plus Bevacizumab | Active comparator | Drug: Sintilimab, Drug: BevacizumabSintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
- At least one measurable lesion based on Recist1.1.
- No prior systemic therapy for HCC.
Key exclusion criteria (2 listed)
- Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
- Any condition that is not suitable for participate in this study as determined by investigator.
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 |
|---|---|---|
| ZG005 for InjectionAlso: ZG005Participants receive ZG005 20 mg/kg IV, Q3W | Drug | ZG005+Bevacizumab |
| Bevacizumab ( Avastin)Participants receive Bevacizumab ( Avastin) 15 mg/kg IV, Q3W | Drug | ZG005+Bevacizumab |
| SintilimabParticipants receive Sintilimab 200mg IV, Q3W | Drug | Sintilimab Plus Bevacizumab |
| BevacizumabAlso: 达攸同Participants receive Bevacizumab 15 mg/kg IV, Q3W | Drug | Sintilimab Plus Bevacizumab |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 3 years
PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1
Overall survival (OS)
Time frame: up to 5 years
2 secondary outcomes
PFS
Time frame: up to 3 years
Objective response rate (ORR)
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 10 Sep 2026.
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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.
Jason Wu study director
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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 ZG005 for Injection, Bevacizumab ( Avastin) and Sintilimab in people with Hepatocellular Carcinoma, run by Suzhou Zelgen 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 6 inclusion and 2 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 10 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 Wei Chen (+86-0512-57309965, weic@zelgen.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: up to 3 years). 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 10 Sep 2026.