Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
详细描述
For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.
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
- •Untreated locally advanced cervical cancer patients with clear pathological diagnosis
- •2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Life expectancy > 6 months
- •Able to tolerate concurrent chemoradiotherapy assessed by researches
- •No obvious active bleeding;
- •Adequate hematological, renal and hepatic functions:
- •No concomitant malignancies
- •Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
- •Voluntarily-signed informed consent.
排除标准
- •Concomitant other malignancies;
- •Patients with metastatic or recurrent disease;
- •Patients received any form of treatment before enrollment;
- •Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
- •Impaired hematological, renal or hepatic functions:
- •Hemoglobin < 9.0 g/dl
- •Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L
- •Platelets > 100 × 109/L
- •Serum ALT/AST > 2.5×UNL
- •Serum Total bilirubin > 1.5× UNL
- •g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)
- •Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
- •Patients with uncontrolled mental diseases;
- •Pregnant or lactating woman;
- •Participating in other clinical trials;
- •Anyone considered not suitable for enrollment by principal investigator;
研究组 & 干预措施
Induction immunotherapy and chemotherapy
Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation
干预措施: Toripalimab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 1 year
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Volume changes of core radiation targets and irradiated normal tissues after induction treatment
时间窗: 5-year
Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
次要结局
- Distant metastasis-free survival(1-year, 2-year)
- Incidence of treatment-related side effects(5-year)
- Progression-free survival(1-year, 2-year)