NCT07489300

Brief Summary

Efficacy and safety of Benmelstobart combined with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (BACON study) in China

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
19mo left

Started Mar 2026

Shorter than P25 for phase_2 ovarian-cancer

Status
not yet recruiting

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

Study Progress12%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

March 24, 2026

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer

Keywords

BenmelstobartAnlotiniboral metronomic Cyclophosphamideepithelial ovarian cancerfallopian tube cancerprimary peritoneal cancer

Outcome Measures

Primary Outcomes (1)

  • progression-free survival (PFS)

    24 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

    from enrollment to the end of treatment at 2 years

Secondary Outcomes (3)

  • CRR

    6 months

  • OS

    5 years

  • AEs

    12 months

Study Arms (1)

Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide

OTHER

Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer

Drug: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide

Interventions

Benmelstobart in combination with Anlotinib and oral metronomic CyclophosphamideDRUG

Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer

Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide

Eligibility Criteria

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

You may qualify if:

  • The age on the day of signing the informed consent form is 18 years or older. 2.Eastern Cooperative Oncology Group performance status of 0-1, with the ability to tolerate chemotherapy.
  • There is measurable disease according to the RECIST 1.1 or irRECIST criteria. 4.The histological types can be serous, endometrioid, clear cell, mucinous or undifferentialed types of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. The original primary tumor needs to be histologically confirmed through the pathological report.
  • Participants can be either platinum-sensitive (with a platinum-free interval(PFI) of ≥6 months before the recent recurrence) or platinum-resistant (with a PFI of \<6 months before the recent recurrence). If the participant has a platinum-sensitive disease, they can only participate in this clinical trial with platinum-based chemotherapy contraindications (such as severe persistent toxicity or a severe hypersensitivity reaction to platinum drugs, or refuse standard treatment).
  • The participants must be willing to undergo hollow needle biopsy or excisional biopsy of tumor lesion within 4 weeks (28 days) before the start of the treatment and after 3 cycles treatment. For participants who are unable to provide new samples (for example, unable to obtain or there are issues related to the safety of the participants), only with the consent of the principal investigator can archived samples be submitted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

anlotinib

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 DisordersFallopian Tube DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

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

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 24, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

March 24, 2026

Record last verified: 2025-07