This study is a randomized, open-label, controlled phase II clinical trial. It is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi). Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Administered intravenously on Day 1 of each 3-week treatment cycle.
Administered intravenously on Day 1 of each 3-week treatment cycle.
Administered intravenously on Day 1 of each 3-week treatment cycle.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progression Free Survival (PFS)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as determined by investigators.
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). For responses categorized as CR or PR, confirmation is required through a subsequent evaluation performed no less than 4 weeks (≥28 days) after the initial assessment.
Time frame: Up to approximately 3 years
Disease Control Rate (DCR)
Defined as the proportion of subjects with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Defined as the time from the first date a subject is assessed as having a confirmed Complete Response (CR) or Partial Response (PR) to the first date of either Progressive Disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall Survival (OS)
Defined as the time from the randomization date to death due to any cause in subjects.
Time frame: Up to approximately 5 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of patients experiencing any grade and grade 3-4 toxicity for each toxicity according to NCI-CTCAE v6.0
Time frame: Up to approximately 3 years
Quality of life: EQ-5D-5L Questionnaire
Overall change from baseline scores in quality of life by cycle and between treatment arms.
Time frame: Up to approximately 3 years
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