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Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.

ConditionsOvarian NeoplasmsOvarian Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFujian Cancer Hospital

About this trial

This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70;Female;

Pathologically (including histologically) confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (hereinafter referred to as ovarian cancer), recurrence within less than 6 months after the last treatment with platinum-containing chemotherapy;

Patients have at least one target lesion with measurable dimensions according to RECIST1.1 criteria;

HRR gene mutation confirmed by testing tissue or blood samples;

Disqualifiers

Other clinical drug experiments in which other experimental research drugs are used concurrently with the study;

Patients with known hypersensitivity to fluzoparib or hypersensitivity to drug-active or inactive ingredients with a similar chemical structure to fluzoparib;

Patients with known hypersensitivity to adebrelimab or hypersensitivity to the active or inactive components of the drug having a similar chemical structure to adebrelimab;

Inability to swallow oral medications and any gastrointestinal disorders that may interfere with the absorption and metabolism of study medications, such as uncontrolled nausea and vomiting, gastrointestinal obstruction or malabsorption;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    20mg/kg，D1，q3W

  • Fuzuloparib

    Drug

    100 mg bid

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Adebrelimab Combined With FuzuloparibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR)

ORR is determined using RECIST v1.1, Defined as the optimal overall response (CR or PR) at the time point assessed from enrollment to the end of neoadjuvant therapy

Time frame
3 years

Secondary outcomes

1

Overall survival(OS)

Defined as the time from the enrollment to death from any cause

Time frame
3 years
2

Progression free survival(PFS)

It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
3 years
3

Disease Control Rate(DCR)

DCR is determined using RECIST v1.1, Defined as the rate of disease control (CR or PR or SD) from enrollment to the end of neoadjuvant therapy.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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