Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)
研究概览
简要总结
To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H/dMMR endometrial cancer.
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
- •Aged 18-75 years.
- •Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma.
- •Laboratory-confirmed dMMR (mismatch repair deficient) endometrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).
- •Stage I-II according to the FIGO 2023 staging system.
- •At least one measurable lesion (RECIST 1.1 criteria).
- •ECOG performance status 0-1, with a life expectancy of ≥12 months.
- •Strong desire for uterine preservation, conservative treatment, or fertility preservation, or inability to tolerate standard surgery due to comorbidities.
- •Adequate organ function within 14 days prior to enrollment.
- •Good follow-up conditions and signed informed consent.
排除标准
- •Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;
- •Prior treatment with immune checkpoint inhibitors;
- •Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.;
- •Concurrent severe dysfunction of vital organs including heart, lung, liver and kidney: alanine aminotransferase/aspartate aminotransferase elevated more than 3 times the upper limit of normal (ULN) and unresponsive to liver-protective therapy; serum creatinine ≥1.5 × ULN; abnormal thyroid function; history of heart failure, unstable angina pectoris, severe arrhythmia, myocarditis, interstitial lung disease, non-infectious pneumonitis or active pulmonary infection, etc.;
- •Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
- •Known hypersensitivity to any component of the study drug;
- •Pregnant or breastfeeding women;
- •Any severe or unstable concomitant disease that, in the investigator's judgment, renders the subject ineligible for this study.
结局指标
主要结局
Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)
时间窗: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)
Clinical Complete Response (cCR): Defined as the complete disappearance of all target lesions as assessed by imaging in subjects who did not undergo surgery, with no appearance of new lesions; or the absence of residual tumor cells in endometrial biopsy specimens obtained under hysteroscopy. Pathological Complete Response(pCR): Defined as the absence of residual tumor cells in the surgically resected tumor tissue specimens from subjects who underwent hysterectomy.
次要结局
未报告次要终点
研究者
Wang Jianliu
Director of the Institute of Obstetrics and Gynecology, Principal Investigator, Clinical Professor
Peking University People's Hospital