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

Primary Purpose

Ovarian Neoplasms, Ovarian Diseases

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Adebrelimab
Fuzuloparib
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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; ECOG PS 0-1; Major organ functions are normal and meet the following criteria:(1) Blood routine inspection standards must meet: (no blood transfusion within 14 days)a.HB≥100g/L, b. WBC≥3×10^9/L c. ANC≥1.5×10^9/L, d.PLT≥100×10^9/L; (2) Biochemical examination must meet the following standards: a. BIL ≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.5×ULN, ALT and AST≤5×ULN in patients with liver metastases; c. Serum Cr≤1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN, unless the patient is receiving anticoagulation, as long as PT or APTT is within the expected range of anticoagulant use; No severe heart, lung, liver or kidney disorders; Women of childbearing age must have a pregnancy test (serum) within 7 days prior to enrollment and have a negative result, and be willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; Estimated survival≥ 12 weeks; Sign a written informed consent form and be able to comply with the visitation and related procedures set out in the programme. Exclusion Criteria: 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; prior treatment with known or probable immune checkpoint inhibitors; Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except vitiligo or recovered childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; Type I diabetes mellitus with a stable dose of insulin; A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation; With unstable systemic diseases, such as hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg), severe arrhythmias, etc.; Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organising pneumonia, drug-induced pneumonia, or active pneumonia on screening-phase CT; There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) cardiac insufficiency above NYHA grade 2 (2) unstable angina (3) acute myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc>470ms; Patients who are pregnant or breastfeeding, or who plan to become pregnant during study treatment; The investigators considered it unsuitable for inclusion.

Sites / Locations

  • Fujian Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adebrelimab Combined With Fuzuloparib

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival(OS)
Defined as the time from the enrollment to death from any cause
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.
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.

Full Information

First Posted
February 23, 2023
Last Updated
October 17, 2023
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05753826
Brief Title
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.
Official Title
A Single-arm, Exploratory Study of Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Ovarian Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adebrelimab Combined With Fuzuloparib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adebrelimab
Intervention Description
20mg/kg,D1,q3W
Intervention Type
Drug
Intervention Name(s)
Fuzuloparib
Intervention Description
100 mg bid
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
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 Outcome Measure Information:
Title
Overall survival(OS)
Description
Defined as the time from the enrollment to death from any cause
Time Frame
3 years
Title
Progression free survival(PFS)
Description
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
Title
Disease Control Rate(DCR)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; ECOG PS 0-1; Major organ functions are normal and meet the following criteria:(1) Blood routine inspection standards must meet: (no blood transfusion within 14 days)a.HB≥100g/L, b. WBC≥3×10^9/L c. ANC≥1.5×10^9/L, d.PLT≥100×10^9/L; (2) Biochemical examination must meet the following standards: a. BIL ≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.5×ULN, ALT and AST≤5×ULN in patients with liver metastases; c. Serum Cr≤1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN, unless the patient is receiving anticoagulation, as long as PT or APTT is within the expected range of anticoagulant use; No severe heart, lung, liver or kidney disorders; Women of childbearing age must have a pregnancy test (serum) within 7 days prior to enrollment and have a negative result, and be willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; Estimated survival≥ 12 weeks; Sign a written informed consent form and be able to comply with the visitation and related procedures set out in the programme. Exclusion Criteria: 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; prior treatment with known or probable immune checkpoint inhibitors; Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except vitiligo or recovered childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; Type I diabetes mellitus with a stable dose of insulin; A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation; With unstable systemic diseases, such as hypertension that cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg), severe arrhythmias, etc.; Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organising pneumonia, drug-induced pneumonia, or active pneumonia on screening-phase CT; There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) cardiac insufficiency above NYHA grade 2 (2) unstable angina (3) acute myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc>470ms; Patients who are pregnant or breastfeeding, or who plan to become pregnant during study treatment; The investigators considered it unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Sun, Doctor
Phone
15959028989
Email
garyhanyu@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Sun, Doctor
Organizational Affiliation
Fujian Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sun, sunyang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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