Advanced Unresectable Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGSHR-2524 Injection
SHR-2524 injection.
DRUGBevacizumab Injection
Bevacizumab injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years old; 2. Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis; 3. The Barcelona clinical liver cancer stage was B or C; 4. Has not previously received systemic antitumor therapy for HCC; 5. At least one measurable lesion according to RECIST v1.1 criteria; 6. Child-Pugh score of A or B7 ; 7. ECOG score 0 -1; 8. The expected survival time was ≥12 weeks; 9. The major organs functioned well; 10. Has signed the informed consent form.
Exclusion criteria
1. Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology; 2. 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; 3. Previous allogeneic organ transplantation (e.g., liver transplantation); 4. The current liver tumor burden is greater than 50% of the total liver volume; 5. CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose; 6. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose; 7. Major vascular disease had occurred within 6 months before the first dose; 8. Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy; 9. Innate or acquired immune deficiency (such as HIV infection); 10. Severe infection occurred within 28 days before the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough serum concentrations (C21d) | 0 - 21 days. | Pharmacokinetics (PK) parameters. |
| Area under curve from Day 0 to Day 21 (AUC0-21d) | 0 - 12 days. | Pharmacokinetics (PK) parameters. |
| Area under curve up to 21 weeks (AUC0-21weeks) | 0 - 12 weeks. | Pharmacokinetics (PK) parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum blood concentration (Cmax) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Time to peak concentration (Tmax) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Area under curve - Time curve from Time 0 to Infinity (AUC0-∞) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Elimination half-life (t1/2) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Rate of clearance (CL/F) | About 9 months. | Pharmacokinetics (PK) parameters. |
| Geometric mean of the apparent volume of distribution of the population (Vz/F) | About 9 months. | Pharmacokinetics (PK) parameters. |
| The number and percentage of anti-drug antibody (ADA) positive participants | About 9 months. | Immunogenicity parameter. |
| Adverse events (AEs) | About 9 months. | Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of adverse events (AEs). |
| Serious adverse events (SAEs) | About 9 months. | Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of serious adverse events (SAEs). |
| Investigator - assessed objective response rate (ORR) based on RECIST v1.1 | About 9 months. | Efficacy parameters. |
| Investigator - assessed duration of response (DoR) based on RECIST v1.1 | About 9 months. | Efficacy parameters. |
| Investigator - assessed disease control rate (DCR) based on RECIST v1.1 | About 9 months. | Efficacy parameters. |
| Investigator - assessed progression-free survival (PFS) based on RECIST v1.1 | About 9 months. | Efficacy parameters. |
| Investigator - assessed overall survival (OS) based on RECIST v1.1 | About 9 months. | Efficacy parameters. |
Countries
China
Contacts
CONTACTYang Wu
Outcome results
None listed