The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
421
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of USTC West District,Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Progression free survival(PFS) by blinded independent review committee(BIRC)
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST 1.1 criteria
Time frame: 2 year
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Time frame: 2.5 year
PFS by investigator
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria
Time frame: 2 year
Objective Response Rate (ORR) by investigator
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: 2 year
Disease Control Rate (DCR) by investigator
Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: 2 year
Objective Response Rate (DOR) by investigator
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: 2 year
ORR by BIRC
Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria
Time frame: 2 year
DCR by BIRC
Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by BIRC according to RECIST 1.1 criteria
Time frame: 2 year
DOR by BIRC
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: 2 year
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time frame: 2.5 year
Quality Of Life (QoL)
use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire
Time frame: 2.5 year
Quality Of Life (QoL)
use EORTC-QLQ-OV28 questionnaire
Time frame: 2.5 year
Serum drug concentrations of BD0801
Serum drug concentrations of BD0801 will be calculated.
Time frame: 2 year
rate of immunogenicity positive reaction
Time frame: 2 year
duration of immunogenicity positive reaction
Time frame: 2 year
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Peking University First Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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