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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fujian
Contact Information
Primary
Yang Sun, Doctor
garyhanyu@sina.com
15959028989
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 37
Treatments
Experimental: Adebrelimab Combined With Fuzuloparib
Related Therapeutic Areas
Sponsors
Leads: Fujian Cancer Hospital

This content was sourced from clinicaltrials.gov