NCT06241105招募中2 期
A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The investigators propose to initiate a study assessing the efficacy and safety of a lower initial dosage of lenvatinib combined with toripalimab in patients suffering from platinum-resistant recurrent ovarian cancer. The objective of this research is to offer a novel therapeutic approach for patients battling relapsed ovarian cancer with platinum resistance.
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
- •Age: 18 to 75 years;
- •Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
- •According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
- •Liver and Kidney Function: Serum creatinine levels should be ≤ 1.5 times the upper limit of the normal range.AST and ALT levels should be ≤ 2.5 times the upper limit of normal, or ≤ 5 times the upper limit of normal if liver metastases are present;total bilirubin should be ≤ 1.5 times the upper limit of the normal range.
- •Participants of reproductive age must consent to the use of effective contraceptive methods throughout the duration of the study.Women of reproductive age must yield a negative result in serum or urine pregnancy tests.Non-lactating patients.
- •Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study.
排除标准
- •Uncontrollable malignant hypertension;
- •Imaging showed that the tumor invaded important blood vessels;
- •Contraindications to the use of antiangiogenic agents;
- •Contraindications to checkpoint inhibitors;
- •Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess;
- •Simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study.
- •Known hypersensitivity to study-related drugs or their excipients;
- •Individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life;
- •Patients judged by the investigator to be inappropriate for participation in the study.
研究组 & 干预措施
Lenvatinib+Toripalimab
Experimental
- Administer 8 mg of Lenvatinib orally, once a day, for continuous usage;
- Administer 240mg of Toripalimab via intravenous infusion, first time seven days post-lenvatinib intake, and subsequently every three weeks thereafter.
干预措施: Lenvatinib+Toripalimab. (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the start of treatment to a minimum of 3 years
This term denotes the duration from the initiation of enrollment to the point of neoplasm progression or death.
次要结局
- Overall Survival (OS)(From the start of treatment to a minimum of 3 years)
- Objective Response Rate (ORR)(From the start of treatment to a minimum of 3 years)
研究者
Fengzhi Feng
professor
Peking Union Medical College Hospital
研究点 (1)
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