ClinicalTrials.gg
Not yet recruitingNCT07813572Updated Sep 10, 2026

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular

A Phase 3 interventional study of ZG005 for Injection and Bevacizumab ( Avastin) in Hepatocellular Carcinoma, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 72 studies testing bevacizumab in Carcinoma, Hepatocellular — 27 open to participants now, 37 under way, 5 of them phase 3. Bevacizumab · Carcinoma, Hepatocellular.

Planned enrollment
5th of 72
600 · median 44
Started
2026
with 5 others
Phase 3
10 of 72
2 open now
Primary completion
2031-09
later than 35 of 36 live
Registered
72nd of 72
by date

Among the 72 studies testing bevacizumab in Carcinoma, Hepatocellular, this one is the 5th largest by planned enrollment, is one of 6 that started in 2026, is one of 10 in phase 3, reaches primary completion later than 35 of the 36 other live ones, and was the 72nd registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

27 of the 72 studies testing bevacizumab in Carcinoma, Hepatocellular are open now, in 11 countries. Recruiting first, the newest first:

22 more — sign in →

By country, each count listing its studies:

All 27 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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

03

Conditions studied

  • Hepatocellular Carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with histologically/ confirmed unresectable or advanced HCC;
  • (ECOG) Performance Status of 0 or 1.
  • Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
  • At least one based on Recist1.1.
  • No prior systemic therapy for HCC.
  • ≤6 , no history of hepatic encephalopathy.

Exclusion criteria

Exclusion Criteria:

  • Active Central nervous system (CNS) or .
  • Any condition that is not suitable for participate in this study as determined by investigator.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    ZG005+Bevacizumab

    ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W

    Drug: ZG005 for Injection · Drug: Bevacizumab ( Avastin)

  • Active comparator
    Sintilimab Plus Bevacizumab

    Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W

    Drug: Sintilimab · Drug: Bevacizumab

Interventions

  • Participants receive ZG005 20 mg/kg IV, Q3W

    Also known as: ZG005

  • Participants receive Bevacizumab ( Avastin) 15 mg/kg IV, Q3W

  • Participants receive Sintilimab 200mg IV, Q3W

  • Participants receive Bevacizumab 15 mg/kg IV, Q3W

    Also known as: 达攸同

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1

    Time frame: up to 3 years

  2. Overall survival (OS)

    Time frame: up to 5 years

Secondary outcomes

  1. PFS

    PFS evaluated by investigator based on RECIST V1.1

    Time frame: up to 3 years

  2. Objective response rate (ORR)

    ORR evaluated by IRC based on RECIST V1.1

    Time frame: up to 3 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2031, 60 months later.

Of 52 industry-sponsored phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 63. This study's planned 60 months is above that.

Counting every sponsor, half of 138 studies reached it within 56 months; a quarter within 43 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2031
CompletionEst.
Sep 2032
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07813572
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2031 (estimated)
Completion
Sep 2032 (estimated)
Last update
Sep 10, 2026

Study contacts

Wei Chen
Contact
weic@zelgen.com
+86-0512-57309965
Jason Wu
study director · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Nilvanstomig · Bevacizumab

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