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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fan, Dr | Contact | 021-64041990 | fan.jia@zs-hospital.sh.cn | |
| Huichuan Sun, Dr | Contact | sun.huichuan@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan | Fudan University | Principal Investigator |
| Huichuan Sun, Dr | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | China |
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| 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. |
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| HLX10 | Drug | HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle. |
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| HLX04 | Drug | HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. |
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| Placebo | Other | Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle. |
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| 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 | 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 | time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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