This trial was designed as a single-arm, open-label, prospective clinical trial to evaluate the efficacy (ORR) and safety (AE incidence) of CapsuleX in combination with cisplatin for platinum-resistant recurrent ovarian cancer (PROC).
The subject can understand the informed consent, voluntarily participate and sign the informed consent;
The subject is at least 18 years old on the day of signing the informed consent;
Subjects with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
Platinum resistance is defined as: a. For subjects who have only received first-line platinum-based therapy, they must have received at least four cycles of platinum-based therapy and achieved disease response (CR or PR), with disease progression occurring between>3 months and ≤6 months after the last platinum-based treatment; b. For subjects who have received more than two lines of platinum-based therapy, disease progression must occur within <6 months after the last platinum-based treatment (at least two cycles).
Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;
History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the following criteria: no related symptoms and at least one recent imaging showing a stable state; or stable for more than 1 month without symptoms after treatment, and no need to use glucocorticoids or anticonvulsants for at least 2 weeks;
Received any investigational drug within 28 days prior to randomization;
Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor indication within 14 days prior to randomization;
Single group
CapsuleX
DrugCapsuleX Combined with Cisplatin
To evaluate the objective response rate (ORR) of CapsuleX combined with cisplatin in platinum-resistant recurrent ovarian cancer patients.
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