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NCT05753826RecruitingPhase 2

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

A Single-arm, Exploratory Study of Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 6 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
37 (estimated)
First submitted
23 Feb 2023
Start date
1 Aug 2023
Primary completion date
31 Dec 2025
Lead sponsor
Fujian Cancer Hospital
NCT number
NCT05753826

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 37
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other clinical drug experiments in which other experimental research drugs are used concurrently with the study;
  • 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;
  • Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organising pneumonia, drug-induced pneumonia, or active pneumonia on screening-phase CT;

Other illness

  • 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;
  • 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.;

Lab values

  • 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;

Other

  • Patients who are pregnant or breastfeeding, or who plan to become pregnant during study treatment;
  • The investigators considered it unsuitable for inclusion.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FujianChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.