This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure.
This is a randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients (≥ 12 years old) with osteosarcoma who have at least second-line treatment failure. Eligible study participants shall be randomized in a 2:1 ratio to the experimental group and the control group. Study participants in the experimental group received HS-20093 at 12.0 mg/kg once every 3 weeks (Q3W), and the study participants continued to receive treatment until objective disease progression or other criteria for treatment discontinuation were met. Study participants in the control group received standard chemotherapy regimen of gemcitabine in combination with docetaxel until disease progression or other criteria for treatment discontinuation were met. The efficacy and safety of the two groups were evaluated after follow-up as per the procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.
Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.
Beijing Jishuitan Hospital affiliated to Capital Medical University
Beijing, China
Peking University People's Hospital
Beijing, China
PFS assessed by IRC as per RECIST 1.1 criteria
PFS is defined as the time interval from the randomization to disease progression as per ICR assessment or death due to any cause.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years.
ORR assessed by IRC as per RECIST 1.1 criteria
Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per ICR per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
DCR assessed by IRC as per RECIST 1.1 criteria
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per ICR per RECIST v1.1
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
DoR assessed by IRC as per RECIST 1.1 criteria
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
ORR assessed by the investigator as per RECIST 1.1 criteria
Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per investigator per RECIST v1.1
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Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
DCR assessed by the investigator as per RECIST 1.1 criteria
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per investigator assessment per RECIST v1.1
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
DoR assessed by the investigator as per RECIST 1.1 criteria
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
PFS assessed by the investigator as per RECIST 1.1 criteria
PFS is defined as the time interval from the randomization to disease progression as per investigator assessment or death due to any cause
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years
OS
Overall survival (OS) is defined as the time interval from randomization to death due to any cause
Time frame: From the date of randomization to the date of death due to any cause; Up to approximately 5 years