Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
NCT ID: NCT05737303
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
538 participants
INTERVENTIONAL
2023-11-27
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer
NCT04807166
Lower Dose Decitabine (DAC)-Primed TC (Carboplatin-Paclitaxel) Regimen in Ovary Cancer
NCT02159820
Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial
NCT05316376
Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer
NCT03818282
S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
NCT00003120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nab-Paclitaxel/carboplatin for systemic therapy after surgery
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
nab-paclitaxel combined with carboplatin
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)
Paclitaxel/carboplatin for systemic therapy
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)
nab-paclitaxel combined with carboplatin
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
nab-paclitaxel combined with carboplatin
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)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
3. Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
4. Written informed consent
5. Expected survival ≥6 months
6. The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
7. Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.
Exclusion Criteria
2. Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
3. Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
4. Patients with central nervous system metastasis or peripheral neuropathy \> grade 1;
5. Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
6. 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;
7. Uncontrolled systemic infection requiring anti-infective treatment;
8. 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;
9. Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
10. Pregnant or lactating women;
11. Those who were considered unsuitable for inclusion by the researchers.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiaxing Maternity and Child Health Care Hospital
OTHER
Zhejiang University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Sun Yat-sen University
OTHER
Qilu Hospital of Shandong University
OTHER
Ningbo No. 1 Hospital
OTHER
Ningbo Women & Children's Hospital
OTHER
Sir Run Run Shaw Hospital
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yaxia Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
Qilu Hospital of Shandong University
Ji'nan, Shandong, China
Yaxia Chen
Hangzhou, Zhejiang, China
Sir Run Run Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Ningbo women's and children's Hospital
Ningbo, Zhejiang, China
The No, 1 People's Hospital of Ningbo
Ningbo, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yanling Feng
Role: primary
Jianhua Yang
Role: primary
Jianhua Qian
Role: primary
Jianwei Zhou
Role: primary
Yaqing Chen
Role: primary
Lingjun Zhao
Role: primary
Yutao Guan
Role: primary
Yan Hu
Role: primary
Xiaojian Yan
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Zeighami S, Soltani M, Khajeh F, Ariafar A, Naghdi-Sedeh N. Testicular papillary serous carcinoma of ovarian type, a rare case report, however an important timely diagnostic issue. Urol Case Rep. 2020 Jun 16;33:101301. doi: 10.1016/j.eucr.2020.101301. eCollection 2020 Nov.
Dueckelmann AM, Fink D, Harter P, Heinzelmann V, Marth C, Mueller M, Reinthaller A, Tamussino K, Wimberger P, Sehouli J. The use of PIPAC (pressurized intraperitoneal aerosol chemotherapy) in gynecological oncology: a statement by the "Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)", the Swiss and Austrian AGO, and the North-Eastern German Society of Gynaecologic Oncology. Arch Gynecol Obstet. 2018 Apr;297(4):837-846. doi: 10.1007/s00404-018-4673-0. Epub 2018 Jan 22.
Perez-Fidalgo JA, Grau F, Farinas L, Oaknin A. Systemic treatment of newly diagnosed advanced epithelial ovarian cancer: From chemotherapy to precision medicine. Crit Rev Oncol Hematol. 2021 Feb;158:103209. doi: 10.1016/j.critrevonc.2020.103209. Epub 2020 Dec 31.
Huang CY, Cheng M, Lee NR, Huang HY, Lee WL, Chang WH, Wang PH. Comparing Paclitaxel-Carboplatin with Paclitaxel-Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer. Int J Environ Res Public Health. 2020 Mar 26;17(7):2213. doi: 10.3390/ijerph17072213.
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.
Ratanajarusiri T, Sriuranpong V, Sitthideatphaiboon P, Poovoravan N, Vinayanuwat C, Parinyanitikul N, Angspatt P, Thawinwisan W, Tanasanvimon S. A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes. Chemotherapy. 2017;62(2):134-139. doi: 10.1159/000450748. Epub 2016 Dec 20.
Kundranda MN, Niu J. Albumin-bound paclitaxel in solid tumors: clinical development and future directions. Drug Des Devel Ther. 2015 Jul 24;9:3767-77. doi: 10.2147/DDDT.S88023. eCollection 2015.
du Bois A, Quinn M, Thigpen T, Vermorken J, Avall-Lundqvist E, Bookman M, Bowtell D, Brady M, Casado A, Cervantes A, Eisenhauer E, Friedlaender M, Fujiwara K, Grenman S, Guastalla JP, Harper P, Hogberg T, Kaye S, Kitchener H, Kristensen G, Mannel R, Meier W, Miller B, Neijt JP, Oza A, Ozols R, Parmar M, Pecorelli S, Pfisterer J, Poveda A, Provencher D, Pujade-Lauraine E, Randall M, Rochon J, Rustin G, Sagae S, Stehman F, Stuart G, Trimble E, Vasey P, Vergote I, Verheijen R, Wagner U; Gynecologic Cancer Intergroup; AGO-OVAR; ANZGOG; EORTC; GEICO; GINECO; GOG; JGOG; MRC/NCRI; NCIC-CTG; NCI-US; NSGO; RTOG; SGCTG; IGCS; Organizational team of the two prior International OCCC. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol. 2005;16 Suppl 8:viii7-viii12. doi: 10.1093/annonc/mdi961. No abstract available.
Wang H, Fan L, Wu X, Han Y. Efficacy evaluation of albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy for primary epithelial ovarian cancer. BMC Womens Health. 2022 Jun 11;22(1):224. doi: 10.1186/s12905-022-01794-y.
Teneriello MG, Tseng PC, Crozier M, Encarnacion C, Hancock K, Messing MJ, Boehm KA, Williams A, Asmar L. Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. J Clin Oncol. 2009 Mar 20;27(9):1426-31. doi: 10.1200/JCO.2008.18.9548. Epub 2009 Feb 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-20230058-R
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.