This study is a multicenter, randomized, controlled, open-label, phase II study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed epithelial ovarian cancer.
This is a multicenter, randomized, controlled, open-label, phase II clinical study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed intermediate to advanced epithelial ovarian cancer, and to provide a basis for recommending the SG001 combination dosing regimen for subsequent studies. This study will enroll patients with histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, FIGO stage II-IV, platinum-resistant relapse (defined as disease progression within 6 months after the last platinum-containing chemotherapy) and non-platinum refractory (defined as disease progression within 4 weeks after the first platinum-containing chemotherapy) with up to three prior lines of platinum-containing systemic chemotherapy, up to two lines of platinum-free systemic chemotherapy, and at least one measurable tumor lesion (according to RECIST 1.1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg q2w
Doxorubicin hydrochloride liposome injection 40mg/m \^2 q4w
1. Objective response rate (ORR, assessed by investigators according to RECIST 1.1 criteria)
ORR is defined as the proportion of all patients with a best evaluation of complete response or partial response (according to RECIST version 1.1 criteria), from the date of administration to the date of patients' withdrawal or study completion or termination.
Time frame: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest.
Progression-free survival (PFS)
PFS measured from the date of administration to the date of investigator firstly assessed disease progression (according to RECIST version 1.1 criteria) or death from any cause (in the absence of progression).
Time frame: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 3 years.
Disease control rate (DCR)
DCR is defined as the proportion of all patients with best a evaluation of complete response or partial response or stable disease (according to RECIST version 1.1 criteria) from the date of administration to the date of patients' withdrawal or study completion or termination.
Time frame: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 2 years.
Overall survival (OS)
OS measured from the date of administration to the date of death from any cause.
Time frame: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 3years..
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Treatment emergent adverse event (TEAEs)
Amount, severity, and duration of TEAEs will be evaluated according to NCI-CTCAE V5.0.
Time frame: From the date of signing Informed Consent Form (ICF) up to 28 days following the last dose of study drug, immune related adverse events will be recorded until 90 days after the last dose.