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Epithelial Ovarian Carcinoma Stage IIIPhase 3NCT05737303

Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

A Phase 3 study testing nab-paclitaxel combined with carboplatin in people with Epithelial Ovarian Carcinoma Stage III and Epithelial Ovarian Carcinoma Stage IV, run by Women's Hospital School Of Medicine Zhejiang University at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
nab-paclitaxel combined with carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
538 participants
Where
11 sitesChina
Study dates
27 Nov 2023to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yaxia Chen, MD contact

+86-571-87061501

chenyax@zju.edu.cn

Yang Li, MD contact

+86-571-87061501

li_yang@zju.edu.cn

11 sites in 1 country

China11 sites, 11 recruiting

  • Sun Yat-Sen University Cancer Hospital

    Guangzhou, Guangdong

    Yanling Feng

    Jihong Liu

    Not yet recruiting

  • Yaxia Chen

    Hangzhou, Zhejiang, 310006

    Yang Li, Doctor, +86-571-87061501, li_yang@zju.edu.cn

    Yaxia Chen

    Recruiting

  • Sir Run Run Hospital

    Hangzhou, Zhejiang

    Jianhua Yang

    Not yet recruiting

  • The First Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang

    Jianhua Qian

    Not yet recruiting

  • The Second Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang

    Jianwei Zhou

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Yaqing Chen

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Ji'nan, Shandong, 250012

    Jie Jiang, qljiangjie@aliyun.com

    Beihua Kong

    Not yet recruiting

  • Ningbo women's and children's Hospital

    Ningbo, Zhejiang

    Lingjun Zhao

    Not yet recruiting

  • The No, 1 People's Hospital of Ningbo

    Ningbo, Zhejiang

    Yutao Guan

    Not yet recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Yan Hu

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Xiaojian Yan

    Not yet recruiting

Other trials in China

About this study

Official title: Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.

Read the detailed description

One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.

Being tested
nab-paclitaxel combined with carboplatin
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-paclitaxel combined with carboplatinDrug

    Also called 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)

Study groups in NCT05737303
Study groupRoleWhat they receive
Nab-Paclitaxel/carboplatin for systemic therapy after surgeryExperimentalNab-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
Receives: Drug: nab-paclitaxel combined with carboplatin
Paclitaxel/carboplatin for systemic therapyActive comparatorPaclitaxel 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)
Receives: Drug: nab-paclitaxel combined with carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Disease progression as first failure

    Measured: 20 months

Secondary outcomes (3)

  1. Objective Remission Rate

    The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.

    Measured: 12 months

  2. Survival

    Overall survival (all-cause death)

    Measured: 3 years, 5 years

  3. Adverse events

    Treatment-related symptoms

    Measured: 3 years, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start27 Nov 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
538 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737303
Sponsor's protocol ID
IRB-20230058-R
Status last verified
Nov 2024
First submitted
2 Jan 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33538338

  • 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.

    PubMed 32690392

  • 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.

    PubMed 33102004

  • 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.

    PubMed 29356953

  • 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.

    PubMed 33388455

  • 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.

    PubMed 32224896

  • 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.

    PubMed 12860964

  • 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.

    PubMed 27997900

  • 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.

    PubMed 26244011

  • 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.

    PubMed 16239238

  • 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.

    PubMed 35690772

  • 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.

    PubMed 19224848

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nab-paclitaxel combined with carboplatin in people with Epithelial Ovarian Carcinoma Stage III and Epithelial Ovarian Carcinoma Stage IV, run by Women's Hospital School Of Medicine Zhejiang University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yaxia Chen, MD (+86-571-87061501, chenyax@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737303, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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