NCT05310344

Brief Summary

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 26, 2022

Last Update Submit

March 26, 2022

Conditions

Ovarian CarcinomaPlatinum-resistant Ovarian CancerRecurrent Ovarian CarcinomaAlbumin-bound PaclitaxelBevacizumabSurvival OutcomesAdverse Events

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1

    24 months

Secondary Outcomes (3)

  • Progression-Free Survival (PFS)

    24 months

  • Overall survival

    36 months

  • Adverse Events

    36 months

Study Arms (1)

Patients with platinum-resistant recurrent epithelial ovarian cancer

EXPERIMENTAL
Combination Product: Albumin-bound paclitaxel and bevacizumab

Interventions

Albumin-bound paclitaxel and bevacizumabCOMBINATION_PRODUCT

Patients will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles.

Patients with platinum-resistant recurrent epithelial ovarian cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18\~75 years old
  • Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • Sufficient bone marrow function;
  • Sufficient liver and renal function;
  • Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women;
  • Patients had no disturbance of consciousness and volunteered to participate in the study.

You may not qualify if:

  • Uncontrolled hypertension
  • Tumor invading vital blood vessels
  • With contraindications to chemotherapy
  • With uncontrolled infection
  • Patients had received anticancer therapy within 3 weeks before enrollment
  • Patients were allergic or intolerant to investigational drugs or its ingredients
  • Patients are not suitable for this trial as judged by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Albumin-Bound PaclitaxelBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831lileigh@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 4, 2022

Study Start

March 27, 2022

Primary Completion

March 27, 2023

Study Completion

March 27, 2024

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

CN(1)