Carcinoma, HepatocellularPhase 2NCT06349980
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
A Phase 2 study testing HLX53 (1000mg), HLX53 (2000mg) and HLX10 in people with Carcinoma, Hepatocellular, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- HLX53 (1000mg), HLX53 (2000mg) and HLX10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2024to 10 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- For patients with cirrhosis, clinical diagnosis is conducted through the American Association for the Study of Liver Diseases (AASLD) standards, while non-cirrhotic patients require a diagnosis confirmed by histological examination.
- No prior systemic treatment for HCC.
- Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.
- Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. The measurable target lesion should not have undergone any prior local treatment (such as radiotherapy, radiofrequency ablation, transarterial chemoembolization (TACE), high-intensity focused ultrasound (HIFU), etc.). A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards.
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- Tumor tissue required for an evaluable PD-L1 expression result at Screening period, if available
- Palliative radiotherapy for bone metastatic lesions was initiated at least 2 weeks prior to the first administration and ≥4 weeks have elapsed since the last therapy; diagnostic liver biopsy was performed at least 1 week prior to the first administration of the medication in this study. Previous local treatment-related AEs have resolved to an NCI-CTCAE grade of ≤ 1.
- Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A and good grade B (≤ 7 points).
- The ECOG physical performance score within 7 days before the first administration of the study drug was 0 or 1.
- Expected survival ≥ 12 weeks.
- Adequate hematologic and end-organ function.
Who cannot join
- Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.
- History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation.
- Within 6 months prior to the first administration of treatment, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal/gastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding.
- 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.
- Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases.
- History of any second primary malignancy within 2 years prior to the first administration of the drug, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma.
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- After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently).
- 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.
- Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study.
- Within 14 days prior to the first administration of the study drug, any active infection requiring systematic anti-infective treatment occurs.
- Manifestations of bleeding (including hemoptysis, abnormal vaginal bleeding, etc.) during screening period, or Grade 2 bleeding events within 3 months before signing the informed consent form, and Grade 3 or higher bleeding events within the past 6 months.
- Known history of severe allergies to any monoclonal antibodies or excipients used in the study medication.
- Previous treatment with any T cell co-stimulation or immune checkpoint therapy (e.g., CTLA-4, PD-1 inhibitors, PD-L1/2 inhibitors, etc.), or previous treatment with bevacizumab or its biosimilars, or previous treatment with anti-TIGIT therapy or related targets (such as CD155, CD112, or CD113 antibodies, etc.).
- The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huichuan Sun, Dr contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Jia Fan, Dr, 021-64041990, fan.jia@zs-hospital.sh.cn
Huichuan Sun, Dr, 021-64041990, sun.huichuan@zs-hospital.sh.cn
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- HLX53 (1000mg), HLX53 (2000mg), HLX10, HLX04, Placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX53 (1000mg)Drug
HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle.
HLX53 (2000mg)Drug
HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle.
HLX10Drug
Also called Serplulimab
HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.
HLX04Drug
Also called Bevacizumab
HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
PlaceboOther
Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HLX53(1000mg)+ HLX10+ HLX04 | Experimental | HLX53+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Receives: Drug: HLX53 (1000mg); Drug: HLX10; Drug: HLX04 |
| HLX53(2000mg)+ HLX10+ HLX04 | Experimental | HLX53+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Receives: Drug: HLX53 (2000mg); Drug: HLX10; Drug: HLX04 |
| Placebo+ HLX10+ HLX04 | Placebo comparator | Placebo+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Receives: Drug: HLX10; Drug: HLX04; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
Secondary outcomes (4)
ORR
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
Measured: up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 36 months)
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results
Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start5 Aug 2024
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Fudan UniversityHuichuan Sun, Dr, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349980
- Sponsor's protocol ID
- HLX53-HCC201
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
- ClinicalTrials.gov ID
- NCT06349980
- Acronym / sponsor ID
- HLX53-HCC201
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 5 Apr 2024 (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 study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
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 |
|---|---|---|
| HLX53(1000mg)+ HLX10+ HLX04 | Experimental | Drug: HLX53 (1000mg), Drug: HLX10, Drug: HLX04HLX53+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| HLX53(2000mg)+ HLX10+ HLX04 | Experimental | Drug: HLX53 (2000mg), Drug: HLX10, Drug: HLX04HLX53+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| Placebo+ HLX10+ HLX04 | Placebo comparator | Drug: HLX10, Drug: HLX04, Other: PlaceboPlacebo+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- For patients with cirrhosis, clinical diagnosis is conducted through the American Association for the Study of Liver Diseases (AASLD) standards, while non-cirrhotic patients require a diagnosis confirmed by histological examination.
- No prior systemic treatment for HCC.
- Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.
Key exclusion criteria (16 listed)
- Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.
- History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation.
- Within 6 months prior to the first administration of treatment, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal/gastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding.
- 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.
- Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases.
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 |
|---|---|---|
| HLX53 (1000mg)HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle. | Drug | HLX53(1000mg)+ HLX10+ HLX04 |
| HLX53 (2000mg)HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle. | Drug | HLX53(2000mg)+ HLX10+ HLX04 |
| HLX10Also: SerplulimabHLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle. | Drug | HLX53(1000mg)+ HLX10+ HLX04, HLX53(2000mg)+ HLX10+ HLX04, Placebo+ HLX10+ HLX04 |
| HLX04Also: BevacizumabHLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. | Drug | HLX53(1000mg)+ HLX10+ HLX04, HLX53(2000mg)+ HLX10+ HLX04, Placebo+ HLX10+ HLX04 |
| PlaceboPlacebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle. | Other | Placebo+ HLX10+ HLX04 |
Primary outcome
ORR
Time frame: up to 24 weeks
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.
4 secondary outcomes
ORR
Time frame: up to 24 weeks
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
OS
Time frame: From randomization to death from any cause (up to approximately 36 months)
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Huichuan Sun, Dr contact
Jia Fan principal investigator
Fudan University
Huichuan Sun, Dr principal investigator
Fudan University
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 HLX53 (1000mg), HLX53 (2000mg) and HLX10 in people with Carcinoma, Hepatocellular, 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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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. Some participants in this study may receive a placebo. 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 Jia Fan, Dr (021-64041990, fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 weeks). 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 18 Dec 2024.