Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
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).
• The subject must have had progression or intolerance during or after the most recent treatment;
• Previous 2-3 line systemic antitumor therapy, with progression within \<6 months after the last platinum treatment and ≥3 months Note: a. New adjuvant and/or adjuvant therapy combined as line 1 treatment; b. Maintenance therapy (including monotherapy, targeted therapy, immunotherapy, and hormone therapy in the initial combination regimen) is considered part of the initial treatment (i.e., not counted separately); c. Lack of evidence of disease progression due to drug switching caused by toxicity is not considered a single treatment line (i.e., not counted separately); d. Insufficiently evaluated treatments without efficacy assessment (≤2 treatment cycles) are not considered a single treatment line (i.e., not counted separately); e. Endocrine therapy and targeted therapy are counted as separate lines unless used as maintenance therapy;
• According to RECIST 1.1, the baseline should have at least 1 measurable lesion. Measurable lesions should not have been previously received Local treatment (such as radiotherapy), or evidence of disease progression after local treatment;
• Expected survival time is greater than or equal to 6 months;
• ECOG score 0 or 1;
⁃ Sufficient organ/marrow function within 7 days prior to randomization, asdefined below;
⁃ Willing to provide archived or fresh tumor tissue samples (if no archived tumor tissue is available and the investigator assesses that it would be risky for the subject to retrieve primary or metastatic tumor tissue samples);
⁃ Able to understand the test requirements and willing and able to comply with the test and follow-up procedures.