RecruitingPhase 2

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

China90 participantsStarted 2024-07-11

Plain-language summary

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Subjects who have received prescribed treatment previously;
✕. 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;
✕. 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;
✕. Have a history of other malignant tumors within 5 years before signing the informed consent;
✕. Subjects with prescribed cardiovascular diseases;
✕. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
✕. Had severe lung disease before randomization;

Progression-free survival (PFS)

Timeframe: Approximately 2 years

NCT IDNCT06434610

SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Xiaohua Wu

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Subjects who have received prescribed treatment previously;
✕. 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;
✕. 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;
✕. Have a history of other malignant tumors within 5 years before signing the informed consent;
✕. Subjects with prescribed cardiovascular diseases;
✕. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
✕. Had severe lung disease before randomization;