Hepatocellular CarcinomaPhase 2NCT03973112

A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

A Phase 2 study testing HLX10 3mg/kg, HLX04 5mg/kg and HLX04 10mg/kg in people with Hepatocellular Carcinoma, run by Shanghai Henlius Biotech at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: HLX10 3mg/kg, HLX04 5mg/kg and HLX04 10mg/kg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 1 siteChina
Study dates: 24 Sep 2019to 15 Dec 2022
Phase: Phase 2
Are there results?: None posted in the registry

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

Subjects who meet all of the following criteria are allowed to be enrolled into this study:
Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures.
The age of signing ICF is ≥ 18 years old and ≤ 75 years old.
Subjects with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, or clinically diagnosed as meeting the criteria for hepatocellular carcinoma of the American association of liver diseases (AASLD).
arm A、B Failure or intolerable toxicity after at least one standard first-line systemic treatment for advanced hepatocellular carcinoma.Previous standard first-line systemic therapy included sorafenib, renvastinib and oxaliplatin based chemotherapy.
arm D never used systemic treatment

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Barcelona Clinic Liver Cancer (BCLC) (appendix I) stage C;BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.
At least one measurable lesion assessed by IRRC according to RECIST v1.1 (appendix ii) has not been treated locally for this lesion (e.g., radiotherapy, radiofrequency ablation, TACE, ultrasound focusing knife, etc.).
The end of previous systematic treatment must be ≥ 2 weeks after the first medication in this study, and the treatment-related AE should be restored to the level of ci -CTCAE ≤ 1 (except hair loss).
Child-pugh liver function rating within 7 days before the first administration of the study drug (appendix iii) : grade A and good grade B (≤ 7 points).
The ECOG physical performance score (appendix iv) for the 7 days prior to the first administration of the study drug was 0 or 1.
Expected survival ≥ 12 weeks.
Subjects of HBsAg (-) and HBcAb (-) were admitted into the group;If HBsAg (+) or HBcAb (+), hbv-dna must be ≤ 500 IU/mL to be included in the group, and those with elevated hbv-dna must agree to receive nucleoside anti-hepatitis b virus treatment.Subjects with negative HCV antibody (-) or hcv-rna were admitted.If hcv-rna is positive, subjects must have ALT and AST ≤ 3×ULN to be enrolled.Subjects with co-infection of hepatitis b and c should be excluded.
Major organs function normally and meet the following criteria (no blood transfusion, albumin, recombinant human thrombogenin or colony stimulating factor (CSF) treatment was received within 14 days prior to the first administration of this study)
Female subjects must meet:
Menopause (defined as having not had menstruation for at least 1 year and having no other known cause other than menopause), or Surgical sterilization (removal of ovaries and/or uterus), or have fertility, but must meet: serum pregnancy test must be negative within 7 days prior to first administration, and , agreed to the annual failure rate < 1% of contraception or abstinence (avoid heterosexual intercourse) (from signed informed consent to test drugs at the end of the time at least 120 days) after the treatment (annual failure rate < 1% of contraceptive methods including bilateral tubal ligation, male sterilization techniques, the correct use can inhibit ovulation hormonal contracepties, releasing hormone of intrauterine contraceptive device and copper intrauterine contraceptive device), and do not breastfeed.
Male subjects must be satisfied: agree with abstinence (avoid heterosexual intercourse) or contraceptive measures, the rules are as follows: spouse or partner has been pregnant for childbearing age women, male subjects must be at the end of the experiment during drug dosage and drug time at least 120 days after the treatment, keep abstinence or use condoms for birth control in order to prevent drug exposure in the embryo.The duration of the clinical study and the reliability of the subjects' preferences and daily lifestyle measures of abstinence should be considered.Regular abstinence (e.g., calender days, ovulation, basal body temperature, or post-ovulation methods) and ejaculation are not acceptable methods of contraception.

Who cannot join

Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.
Other active malignancies within 5 years prior to the first administration of the study drug.Curable localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the prostate, cervical carcinoma in situ, and carcinoma in situ of the breast, can be included in the group.
People who are ready to undergo or have received organ or bone marrow transplants.
After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently).
Symptomatic, untreated, or progressive central nervous system (CNS) or meningeal metastasis.Asymptomatic subjects treated for CNS lesions can be enrolled if all of the following criteria are met:

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in addition to CNS, there must be lesions that can be measured according to RECIST v1.1;
the patient had no history of intracranial or spinal bleeding;
metastatic lesions were limited to cerebellum or supratentorial areas (i.e., no mesencephalon, pons, medulla or spinal cord metastatic lesions);
there was no evidence of progress between the completion of CNS oriented therapy and the start of research and treatment;
the patients did not receive stereotactic radiotherapy within 7 days before the study treatment, did not receive whole-brain radiotherapy within 14 days before the study treatment, and did not receive neurosurgical resection within 28 days before the study treatment;
patients have no need for continuous use of glucocorticoids in the treatment of CNS diseases.Stable doses of anticonvulsant therapy are permitted;
asymptomatic patients with newly detected CNS metastases during screening are eligible to participate in the study after receiving radiotherapy or surgical treatment, and there is no need to repeat screening of brain scan results.
Cerebrovascular accident, myocardial infarction, unstable angina pectoris and poorly controlled arrhythmia occurred within half a year (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women) (QTc interval was calculated by Fridericia formula).
According to the New York heart association (NYHA) standard (appendix 5) levels Ⅲ or Ⅳ cardiac insufficiency or heart colour to exceed examination: LVEF, left ventricular ejection fraction < 50%.
A history of hepatic encephalopathy.
According to the images, portal vein invasion, inferior vena cava or cardiac involvement of HCC main portal branch (Vp4) were present.Patients with cancer thrombus in main portal vein but smooth blood flow in contralateral branch can be enrolled.
Involving major airways, vessels, or large mediastinal mass located centrally (< 30 mm from the crest).
Human immunodeficiency virus (HIV) infection.
Active tuberculosis.
Patients with previous and current cases of interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity.
Known activity or autoimmune disease or history.
The study drug was treated with live attenuated vaccine within 28 days prior to its first administration.
Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day or equivalent dose of prednisone) or other immunosuppressants within 14 days prior to or during the study.In the absence of active autoimmune disease, the inhalation or topical use of steroids, or adrenal hormone replacement at doses less than 10 mg/ day of prednisone efficacy, is permitted.
Within 14 days prior to the first administration of the study drug, any active infection requiring systematic anti-infective treatment occurs.
Major surgery was performed within 28 days prior to the first administration of the study drug. Major surgery in this study was defined as the minimum recovery time of 3 weeks after surgery before the surgery treated in this study could be performed.

Trial locations and contacts

1 site in 1 country.

China1 site

Ethics committee of zhongshan hospital affiliated to fudan university
Shanghai

Other trials in China

About this study

Official title: A Single-arm, Open, Multicenter, Phase II Clinical Study Evaluating the Use of HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) in Combination With HLX04 (Recombinant Anti-vegf Humanized Monoclonal Antibody Injection) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

This trial is a single-arm, open, multicenter phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX10 + HLX04 intravenous infusion, every two weeks, lose treatment until clinical benefit, toxicity, the subjects of the resistance or the doctor decided to suspend the treatment, tested subjects death revocation of informed consent, subjects, subjects of pregnancy, not to plan or program requirement from, or management reasons, treatment for up to 2 years (before).

Conditions: Hepatocellular Carcinoma
Being tested: HLX10 3mg/kg, HLX04 5mg/kg, HLX04 10mg/kg
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HLX10 3mg/kgDrug
anti-PD-1
HLX04 5mg/kgDrug
anti-VEGF, a biosimilar to Avastin
HLX04 10mg/kgDrug
anti-VEGF, a biosimilar to Avastin

Study groups in NCT03973112
Study group	Role	What they receive
HLX10 3 mg/kg + HLX04 5 mg/kg	Experimental	HLX10 3 mg/kg + HLX04 5 mg/kg, as second-line treatment or above Receives: Drug: HLX10 3mg/kg; Drug: HLX04 5mg/kg
HLX10 3 mg/kg + HLX04 10 mg/kg	Experimental	HLX10 3 mg/kg + HLX04 10 mg/kg,as second-line treatment or above Receives: Drug: HLX10 3mg/kg; Drug: HLX04 10mg/kg
HLX10	Experimental	HLX10 3mg/kg, as second-line treatment or above Receives: Drug: HLX10 3mg/kg
HLX10+HLX04 1L treatment	Experimental	HLX10 3 mg/kg + HLX04 10 mg/kg: as first-line treatment Receives: Drug: HLX10 3mg/kg; Drug: HLX04 10mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
Objective response rate(assessed by independent radiological review
Measured: up to 2 years

Secondary outcomes (7)

ORR
Objective response rate (assessed by the investigators based on the RECISTv1.1
Measured: up to 2 years
12-month OS rate
12-month overall survival rate
Measured: from the date of first dose unitl the date of 12-month
OS
Overall survival (OS)
Measured: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
12-month PFS rate
12-month progression-free survival (PFS) rate
Measured: the proportion of subjects who have time interval over 12 months between the first dose and disease progression or death
PFS
Progression-free survival (assessed by independent radiological review
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
PFS
Progression-free survival (assessed by the investigators based on RECIST v1.1)
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
DOR
Duration of response
Measured: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201915 Dec 2022

First posted4 Jun 2019
Study start24 Sep 2019
Primary completion15 Jun 2022 (estimated)
Study completion15 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
More trials run by Shanghai Henlius BiotechThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03973112
Sponsor's protocol ID: HLX10-008-HCC201
Status last verified: Jul 2021
First submitted: 2 Jun 2019
Last updated: 12 Jan 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
PubMed 40932107
Ren Z, Shao G, Shen J, Zhang L, Zhu X, Fang W, Sun G, Bai Y, Wu J, Liu L, Yuan Y, Zhang J, Li Z, Zhang L, Yin T, Wu J, Hou X, Yu H, Li J, Wang Q, Zhu J, Fan J; Serplulimab-HCC Investigators. Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04 in the first-line treatment of advanced hepatocellular carcinoma. Cancer Immunol Immunother. 2025 Jan 3;74(2):69. doi: 10.1007/s00262-024-03917-w.
PubMed 39751879

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open, Multicenter, Phase II Clinical Study Evaluating the Use of HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) in Combination With HLX04 (Recombinant Anti-vegf Humanized Monoclonal Antibody Injection) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients
ClinicalTrials.gov ID: NCT03973112
Acronym / sponsor ID: HLX10-008-HCC201
Conditions: Hepatocellular Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 123 participants (actual)
Lead sponsor: Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
Study start: 24 Sep 2019 (actual)
Primary completion: 15 Jun 2022 (estimated)
Study completion: 15 Dec 2022 (estimated)
First posted: 4 Jun 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
HLX10 3 mg/kg + HLX04 5 mg/kg	Experimental	Drug: HLX10 3mg/kg, Drug: HLX04 5mg/kgHLX10 3 mg/kg + HLX04 5 mg/kg, as second-line treatment or above
HLX10 3 mg/kg + HLX04 10 mg/kg	Experimental	Drug: HLX10 3mg/kg, Drug: HLX04 10mg/kgHLX10 3 mg/kg + HLX04 10 mg/kg,as second-line treatment or above
HLX10	Experimental	Drug: HLX10 3mg/kgHLX10 3mg/kg, as second-line treatment or above
HLX10+HLX04 1L treatment	Experimental	Drug: HLX10 3mg/kg, Drug: HLX04 10mg/kgHLX10 3 mg/kg + HLX04 10 mg/kg: as first-line treatment

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Subjects who meet all of the following criteria are allowed to be enrolled into this study:
Menopause (defined as having not had menstruation for at least 1 year and having no other known cause other than menopause), or Surgical sterilization (removal of ovaries and/or uterus), or have fertility, but must meet: serum pregnancy test must be negative within 7 days prior to first administration, and , agreed to the annual failure rate < 1% of contraception or abstinence (avoid heterosexual intercourse) (from signed informed consent to test drugs at the end of the time at least 120 days) after the treatment (annual failure rate < 1% of contraceptive methods including bilateral tubal ligation, male sterilization techniques, the correct use can inhibit ovulation hormonal contracepties, releasing hormone of intrauterine contraceptive device and copper intrauterine contraceptive device), and do not breastfeed.
Male subjects must be satisfied: agree with abstinence (avoid heterosexual intercourse) or contraceptive measures, the rules are as follows: spouse or partner has been pregnant for childbearing age women, male subjects must be at the end of the experiment during drug dosage and drug time at least 120 days after the treatment, keep abstinence or use condoms for birth control in order to prevent drug exposure in the embryo.The duration of the clinical study and the reliability of the subjects' preferences and daily lifestyle measures of abstinence should be considered.Regular abstinence (e.g., calender days, ovulation, basal body temperature, or post-ovulation methods) and ejaculation are not acceptable methods of contraception.

Key exclusion criteria (26 listed)

Subjects who meet any of the following criteria are not allowed to be enrolled in this study:

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
HLX10 3mg/kganti-PD-1	Drug	HLX10, HLX10 3 mg/kg + HLX04 10 mg/kg, HLX10 3 mg/kg + HLX04 5 mg/kg, HLX10+HLX04 1L treatment
HLX04 5mg/kganti-VEGF, a biosimilar to Avastin	Drug	HLX10 3 mg/kg + HLX04 5 mg/kg
HLX04 10mg/kganti-VEGF, a biosimilar to Avastin	Drug	HLX10 3 mg/kg + HLX04 10 mg/kg, HLX10+HLX04 1L treatment

Primary outcome

ORR
Time frame: up to 2 years
Objective response rate(assessed by independent radiological review

7 secondary outcomes

ORR
Time frame: up to 2 years
12-month OS rate
Time frame: from the date of first dose unitl the date of 12-month
OS
Time frame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
12-month PFS rate
Time frame: the proportion of subjects who have time interval over 12 months between the first dose and disease progression or death
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
DOR
Time frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
Derived from this study: PubMed 40932107Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.
Derived from this study: PubMed 39751879Ren Z, Shao G, Shen J, Zhang L, Zhu X, Fang W, Sun G, Bai Y, Wu J, Liu L, Yuan Y, Zhang J, Li Z, Zhang L, Yin T, Wu J, Hou X, Yu H, Li J, Wang Q, Zhu J, Fan J; Serplulimab-HCC Investigators. Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04 in the first-line treatment of advanced hepatocellular carcinoma. Cancer Immunol Immunother. 2025 Jan 3;74(2):69. doi: 10.1007/s00262-024-03917-w.

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The Vanguard Study: Testing a New Way to Screen for Cancer
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 HLX10 3mg/kg, HLX04 5mg/kg and HLX04 10mg/kg in people with Hepatocellular Carcinoma, run by Shanghai Henlius Biotech 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 17 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03973112, which also lists 2 linked publications.

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 12 Jan 2022.