A Study of SHR-2524 Plus Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
About this trial
This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old;
Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
The Barcelona clinical liver cancer stage was B or C;
Has not previously received systemic antitumor therapy for HCC;
Disqualifiers
Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled;
Previous allogeneic organ transplantation (e.g., liver transplantation);
The current liver tumor burden is greater than 50% of the total liver volume;
Trial design
Design model
Single group
Treatments tested in this trial
SHR-2524 Injection
DrugSHR-2524 injection.
Bevacizumab Injection
DrugBevacizumab injection.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: SHR-2524 plus bevacizumab groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Trough serum concentrations (C21d)
Pharmacokinetics (PK) parameters.
Time frame
0 - 21 days.2
Area under curve from Day 0 to Day 21 (AUC0-21d)
Pharmacokinetics (PK) parameters.
Time frame
0 - 12 days.3
Area under curve up to 21 weeks (AUC0-21weeks)
Pharmacokinetics (PK) parameters.
Time frame
0 - 12 weeks.Secondary outcomes
1
Maximum blood concentration (Cmax)
Pharmacokinetics (PK) parameters.
Time frame
About 9 months.2
Time to peak concentration (Tmax)
Pharmacokinetics (PK) parameters.
Time frame
About 9 months.3
Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)
Pharmacokinetics (PK) parameters.
Time frame
About 9 months.4
Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)
Pharmacokinetics (PK) parameters.
Time frame
About 9 months.Sponsors and contacts
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Source ClinicalTrials.gov