Combining B013 with Paclitaxel for treating platinum-resistant recurrent ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of the drug B013 in combination with Paclitaxel for patients suffering from platinum-resistant recurrent ovarian cancer. Participants will receive either the combination treatment or a placebo, and their responses will be monitored to determine the effectiveness of the therapy. The study aims to enroll patients who meet specific criteria, including having measurable lesions and a performance status of 0 or 1. The goal is to provide a new treatment option for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who have received prescribed treatment previously;
2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
3. Subjects with known central nervous system metastasis and multiple bone metastasis;
4. 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;
5. Have a history of other malignant tumors within 5 years before signing the informed consent;
6. Subjects with prescribed cardiovascular diseases;
7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
8. Had severe lung disease before randomization;
9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
14. Female subjects who are pregnant or breastfeeding;
15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, China Recruiting
• XiangYa Hospital CentralSouth University
  Changsha, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, China Recruiting
• Cancer Hospital of Shandong First Medical University
  Jinan, China Recruiting

Study contacts

• Study coordinator: Xiaohua Wu
• Email: JJYIN555@163.com
• Phone: 0086-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.