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Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer

ConditionsOvarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Benmelstobart in combination with Anlotinib and oral metronomic CyclophosphamideOther 1 intervention

Trial outcomes

Primary outcomes

1

progression-free survival (PFS)

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

Time frame
from enrollment to the end of treatment at 2 years

Secondary outcomes

1

CRR

The objective response rate is evaluated simultaneously by using the RECIST1.1 criteria (Response Evaluation Criteria for solid Tumors) and the immune-related Response Criteria (irRECIST).

Time frame
6 months
2

OS

OS is defined as the time from the date of randomization until death

Time frame
5 years
3

AEs

Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: