Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer
NCT07776171 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176
Last updated 2026-08-20
Summary
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).
Conditions
- Ovarian Cancer
- Platinum Sensitive Ovarian Cancer (PSOC)
Interventions
- DRUG
-
Trastuzumab Rezetecan (SHR-A1811)
Administered intravenously on Day 1 of each 3-week treatment cycle.
- DRUG
-
Administered intravenously on Day 1 of each 3-week treatment cycle.
- DRUG
-
Administered intravenously on Day 1 of each 3-week treatment cycle.
- DRUG
-
Administered intravenously.
- DRUG
-
Carboplatin + Paclitaxel
Administered intravenously.
- DRUG
-
Carboplatin + pegylated liposomal doxorubicin
Administered intravenously.
- DRUG
-
Carboplatin + Gemcitabine
Administered intravenously
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-03-30
- Completion
- 2030-05-30
Countries
- China
Study Locations
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