This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.
The subjects were fully informed, voluntarily signed the informed consent, and were willing and able to follow the planned visit, research treatment plan, laboratory examination and other research procedures.
Female subjects aged ≥ 18 and ≤ 70 at the time of signing the informed consent.
Malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer were confirmed by histology or pathology.
Subjects had at least one measurable lesion defined by RECIST v1.1.
It has clear cell, mucinous or sarcomatous histology, contains mixed tumors of any histological type, or low-grade/borderline ovarian cancer.
In platinum refractory ovarian cancer subjects, platinum refractory was defined as the best response during the first platinum containing regimen treatment as disease progression or recurrence, or disease recurrence or progress within 4 weeks after the end of platinum containing regimen treatment.
Other malignant tumors within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid.
Received nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; received anti-tumor treatment within 4 weeks or 5 half lives (whichever is shorter) before the first use of the study drug, including chemotherapy, radiotherapy, biological targeted therapy, immunotherapy, etc; Oral fluorouracil, small molecule targeted drugs and endocrine therapy were used 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is shorter); Traditional Chinese medicine or Chinese patent medicine with anti-tumor indications were used within 2 weeks before the first use of the study drug.
Single group
Utidelone Capsules
Drug60 mg/m2 orally, days 1 to 5, per cycle
Fruquintinib Capsules
Drug5 mg orally, days 1 to 14, per cycle
ORR
Objective response rate, according to RECIST v1.1
CA-125 remission rate
evaluated according to gcic CA-125 standard
PFS
Progression-free survival, according to RECIST v1.1
OS
Overall survival, according to RECIST v1.1
AEs
Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.
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This trial is not recruiting at the moment. You can still explore other options:
