Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment... | NCT05737303

NCT05737303

Status Module

Name	Class
Jiaxing Maternity and Child Health Care Hospital	OTHER
Zhejiang University	OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nab-Paclitaxel/carboplatin for systemic therapy after surgery	Experimental	Nab-Paclitaxel/carboplatin q3 weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC（area under the curve） 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC（area under the curve）2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles	Drug: nab-paclitaxel combined with carboplatin
Paclitaxel/carboplatin for systemic therapy	Active Comparator	Paclitaxel 175 mg/m² IV followed by carboplatin AUC（area under the curve）5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC（area under the curve） 2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)	Drug: nab-paclitaxel combined with carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nab-paclitaxel combined with carboplatin	Drug	Nab-Paclitaxel/carboplatin q3weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC（area under the curve） 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC（area under the curve）2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles Paclitaxel 175 mg/m² IV followed by carboplatin AUC（area under the curve）5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC（area under the curve）2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)

Outcomes Module

Measure	Description	Time Frame
Progression Free Survival	Disease progression as first failure	20 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Remission Rate	The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.	12 months
Survival	Overall survival (all-cause death)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO（International Federation of Gynecology and Obstetrics）stage
Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
Written informed consent
Expected survival ≥6 months
The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.

Exclusion Criteria:

Patients with low malignant potential ovarian tumors;
Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA（New York Heart Association） criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicated by color Doppler ultrasonography;
Uncontrolled systemic infection requiring anti-infective treatment;
Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
Pregnant or lactating women;
Those who were considered unsuitable for inclusion by the researchers.

Name	Role	Phone	Extension	Email
Yaxia Chen, MD	Contact	+86-571-87061501		chenyax@zju.edu.cn
Yang Li, MD	Contact	+86-571-87061501		li_yang@zju.edu.cn

Name	Affiliation	Role
Yaxia Chen, MD	Study Principal Investigator	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen University Cancer Hospital	Not yet recruiting	Guangzhou	Guangdong		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33538338	Result	Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
32690392	Result	Zheng L, Cui C, Shi O, Lu X, Li YK, Wang W, Li Y, Wang Q. Incidence and mortality of ovarian cancer at the global, regional, and national levels, 1990-2017. Gynecol Oncol. 2020 Oct;159(1):239-247. doi: 10.1016/j.ygyno.2020.07.008. Epub 2020 Jul 18.

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube Neoplasms

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D010051	Ovarian Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals