Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT06434610

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

Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05

90

Participants Needed

17

Research Sites

129 weeks

Total Duration

On this page

Sponsors

S

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead Sponsor

S

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female subjects who voluntarily agree to participate and sign informed consent
  • Diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by tissue examination
  • Cancer must be platinum-resistant and recurrent
  • ECOG performance status of 0 or 1
  • Expected survival longer than 12 weeks
  • At least one measurable tumor lesion
  • Normal major organ function
  • Fertile participants agree to use reliable contraception from consent signing to 6 months after last dose
Not Eligible

You will not qualify if you...

  • Prior prescribed treatment for this cancer
  • Current use of anti-tumor traditional Chinese patent medicines at consent signing
  • Known metastases in the central nervous system or multiple bone metastases
  • Clinical symptoms of pleural effusion, pericardial effusion, or ascites needing drainage before randomization, or had drainage within 2 weeks prior
  • History of other cancers within 5 years before consent
  • Presence of prescribed cardiovascular diseases
  • Infections requiring intravenous antibiotics within 2 weeks before randomization
  • Severe lung disease before randomization
  • Peripheral nerve toxicity greater than grade 2 or other reversible toxicity greater than grade 1 from prior treatment
  • Surgery within 28 days prior to randomization without recovery from adverse effects
  • Participation in another clinical trial within 30 days before randomization involving unmarketed investigational drugs
  • Known allergy to B013 or paclitaxel components
  • History of substance abuse, alcohol or drug use, neurological or psychiatric disorders
  • Pregnant or breastfeeding females
  • Other conditions judged unsuitable by researchers or sponsors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Beijing Cancer Hospital

Beijing, China

Actively Recruiting

2

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Actively Recruiting

3

XiangYa Hospital CentralSouth University

Changsha, China

Actively Recruiting

4

Fujian Cancer Hospital

Fuzhou, China

Actively Recruiting

5

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Actively Recruiting

6

Cancer Hospital of Shandong First Medical University

Jinan, China

Actively Recruiting

7

Qilu Hospital of Shandong University

Jinan, China

Actively Recruiting

8

Yunnan Cancer Hospital

Kunming, China

Actively Recruiting

9

Guangxi Medical University Cancer Hospital

Nanning, China

Actively Recruiting

10

Fudan University Shanghai Cancer center

Shanghai, China

Actively Recruiting

11

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Actively Recruiting

12

The Second Hospital of Hebei Medical University

Shijiazhuang, China

Actively Recruiting

13

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Actively Recruiting

14

Shananxi Provincial Cancer Hospital

Xi'an, China

Actively Recruiting

15

The First Affiliated Hospital of Xiamen University

Xiamen, China

Actively Recruiting

16

Yibin city second people's Hospital

Yibin, China

Actively Recruiting

17

Henan Cancer Hospital

Zhengzhou, China

Actively Recruiting

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Research Team

X

Xiaohua Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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