The Efficacy and Safety of Tislelizumab Combined With Taxanes and Platinum as Neoadjuvant Therapy for Patients With Local Advanced Cervical Carcinoma， an Open Lable，Single-center, Exploratory Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Major pathological response (MPR) rate
研究概览
简要总结
The goal of this clinical trail is to investigate the efficacy and safety of PD-1 antibody Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
详细描述
This phase I study is being conducted to establish efficacy and safety of Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
All enrolled patients will receive same intervention. Treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive Tislelizumab plus TP regimen before surgery for 3 cycles. After treatment, radiographic evaluation will be performed to assess clinical efficacy. Patients who have objective response will undergo radical surgery. Patients who are disease stable or progression will undergo radical chemoradiotherapy. The primary endpoint is major pathological response rate (MPR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cervical squamous cell carcinoma.
- •Clinical staging FIGO IB2-IIB, treatment naive.
- •Female patients aged≥18 years.
- •ECOG performance status 0 or 1, expected lifetime≥3 months.
- •Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥90g/L, ALT/AST ≤2.5x ULN, Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- •HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
- •Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- •Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
排除标准
- •Pregnancy or children bearing potential.
- •brain or meningeal metastasis.
- •With second primary malignant diseases.
- •With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
- •With uncontrollable complications
- •Inadequate organ function
- •Known hypersensitivity reaction to any of the study drugs or components.
- •Other unsuitable conditions determined by investigators.
研究组 & 干预措施
Tislelizumab plus TP regimen as neoadjuvant therapy for local advanced cervical carcinoma
Experimental:
Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin The subjects enrolled in this trial will receive tislelizumab 200mg ivgtt d1, paclitaxel (175mg/m2 ivgtt d1) or docetaxel (75mg/m2 ivgtt d1), cisplatin (75mg/m2 ivgtt d1) or carboplatin (AUC=5 ivgtt d1). The regimen will be repeated every 3 weeks for 3 cycles. Chemotherapy regimen will be selected by investigators.
Subjects will be enrolled serially.
干预措施: Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin (Drug)
结局指标
主要结局
Major pathological response (MPR) rate
时间窗: Up to approximately 8 weeks following completion of neoadjuvant treatment
Major pathological response rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
次要结局
- Relapse free survival (RFS)(Up to approximately 36 months)
- Overall survival (OS)(Up to approximately 60 months)
- Pathological Complete Response (pCR) Rate(Up to approximately 8 weeks following completion of neoadjuvant treatment)
- Objective response rate (ORR)(Up to 30 days after last completion of neoadjuvant treatment)
- Disease free survival (DFS)(Up to approximately 36 months)
- Adverse Events(Up to approximately 12 months)