Efficacy of Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer: A Single-Arm, Single-Center Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- median progression-free survival (PFS)
研究概览
简要总结
This study is a single-arm, single-center prospective clinical study that will evaluate the clinical feasibility and efficacy of immunotherapy combined with chemotherapy in the neoadjuvant treatment of ovarian cancer, in order to explore the progression-free survival of the study population.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease;
- •Female patients aged 18 to 75 years;
- •Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures;
- •Candidates for cytoreductive surgery (debulking surgery);
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Estimated life expectancy of at least 6 months;
- •Women of childbearing potential must agree to use effective contraception during the study period, and a negative serum or urine pregnancy test is required prior to enrollment;
- •Adequate organ function.
排除标准
- •Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma.
- •Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening.
- •Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis.
- •History of other malignancies within 3 years, except for adequately treated curable cancers (e.g., skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, or carcinoma in situ of the breast).
- •Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies.
- •Major surgery within 4 weeks before study treatment, or planned major surgery during the study period.
- •Severe cardiovascular or cerebrovascular disease.
- •Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia.
- •Known hypersensitivity to study drugs or their components.
- •Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.
研究组 & 干预措施
Experimental Arm
Participants will receive immunotherapy combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by interval cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively according to pathological results.
干预措施: Neoadjuvant Therapy Plus Surgery (Procedure)
结局指标
主要结局
median progression-free survival (PFS)
时间窗: From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months.
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.
次要结局
未报告次要终点