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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.

ConditionCarcinoma, Hepatocellular
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • HLX10

    Drug

    HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.

  • HLX04

    Drug

    HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

  • Placebo

    Other intervention

    Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.

Treatment groups

117 Participants
are divided into 3 treatment groups
Group A: HLX53(1000mg)+ HLX10+ HLX04Experimental treatment 3 interventions
Group B: HLX53(2000mg)+ HLX10+ HLX04Experimental treatment 3 interventions
Group C: Placebo+ HLX10+ HLX04Placebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Time frame
up to 24 weeks
2

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.

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

Secondary outcomes

1

ORR

Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)

Time frame
up to 24 weeks
2

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.

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
3

OS

Overall Survival

Time frame
From randomization to death from any cause (up to approximately 36 months)
4

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 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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