This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
Participants voluntarily join this trial and sign an informed consent form.
Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.
Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.
No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.
Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.
Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.
Participants with a history of or concurrent other malignancies, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥5 years prior to randomization with evidence of no recurrence or metastasis.
Participants with a history of interstitial pneumonia/interstitial lung disease requiring steroid treatment, non-infectious pneumonia (such as radiation pneumonitis), current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonia, or other active pneumonia; or those with severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or other lung damage within 6 months prior to randomization.
Parallel
trastuzumab
Drugtrastuzumab
bevacizumab
Drugbevacizumab
Dose limited toxicity (DLT)
Progression Free Survival (PFS)
AEs+SAEs
Ctrough
ADA
Overall survival (OS)
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This trial is not recruiting at the moment. You can still explore other options:
