Adebrelimab Combined with Non-platinum Chemotherapy and Fuzuloparib in the Treatment of Patients with Recurrent Platinum-resistant Ovarian Cancer (Sunrise Trial): a Single-Arm, Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus Non-platinum chemotherapy and Fuzuloparib (PARP inhibitor) induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib in platinum-resistant relapsed/metastatic ovarian cancer.
详细描述
Patients with platinum-resistant relapsed/metastatic ovarian cancer are treated with adebrelimab (PD-L1 inhibitor) plus Non-platinum chemotherapy and Fuzuloparib (PARP inhibitor) induction therapy for 6 cycles followed by maintenance therapy with adebrelimab plus fluzoparib
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 six 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 seven days before enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial period and eight 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 program.
排除标准
- •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.
研究组 & 干预措施
Immunotherapy group
Drug: Adebrelimab, Non-platinum chemotherapy（Doxorubicin liposome/Paclitaxel-albumin/ or Gemcitabine）, fluzoparib Intervention：Adebrelimab plus Non-platinum chemotherapy（Doxorubicin liposome/Paclitaxel-albumin/ or Gemcitabine） induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib.
干预措施: immunotherapy（Adebrelimab） (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Objective Response Rate(ORR) was defined as the percentage of participants with the best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, defined as the best response recorded from the start of the study treatment until disease progression/recurrence or death. Participants needed two consecutive assessments of PR or CR to be responders. Only participants with measurable disease at baseline were included in the analysis of BOR, and those who did not have any evaluable post-baseline assessments were classified as not evaluable.
次要结局
- Progression-free survival (PFS)(From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months)
- Overall survival (OS)(From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months))
- Adverse events (AEs)(from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months)
- Disease Control Rate(DCR)(From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months)