A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Korábbi kezelés

• Subjects who have received prescribed treatment previously;
• Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
• Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
• Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was > grade 2, and other reversible toxicity was > grade 1;
• Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
• Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;

Más betegség

• Have a history of other malignant tumors within 5 years before signing the informed consent;
• Subjects with prescribed cardiovascular diseases;
• Had severe lung disease before randomization;
• Subjects who are known to be allergic to any component of B013 or paclitaxel.
• Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;

Egyéb

• Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
• Subjects with known central nervous system metastasis and multiple bone metastasis;
• Female subjects who are pregnant or breastfeeding;
• Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.

• Subjects who voluntarily participate in this study and sign informed consent form;
• Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
• ECOG performance status of 0 or 1；
• Expected survival > 12 weeks;
• The subject has at least one measurable lesion;
• Normal function of major organs;
• The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.