NCT04731038Unknown1 期
Combination of Paclitaxel, Cisplatin\Carboplatin With Toripalimab and Anlotinib for First Line Treatment of Advanced Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety: adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a single center phase 1 trail to observe safety and efficacy of Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib as first-line regimen to treat the patient with metastatic 、persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).
详细描述
Advanced cervical cancer patients with metastatic, persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both will be treated by Paclitaxel plus Cisplatin\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female patients aged≥18 years.
- •Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites.
- •Patients with advanced or metastatic disease who have disease progression after radical surgery、radical platinum-based concurrent chemoradiotherapy or both （Stage IA-IVA）, with measurable lesions.
- •ECOG performance status 0 or 2, expected lifetime≥3 months.
- •Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥100x109/L, Hemoglobin (Hb) ≥100g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤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
- •Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- •known hypersensitivity reaction to any of the study drugs or components.
- •Other unsuitable conditions determined by investigators.
研究组 & 干预措施
Experimental
Experimental
Anlotinib 12mg qd. po. d1-d14 q3w Toripalimab 240mg ivgtt. d1 q3w Paclitaxel 135mg/m2 ivgtt. d1 q3w Cisplatin 50mg/m2 ivgtt. d1 q3w Carboplatin AUC=5 ivgtt. d1 q3w
干预措施: Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin (Drug)
结局指标
主要结局
Safety: adverse events as assessed by CTCAE v5.0
时间窗: 36 months
次要结局
- Progression free survival(36 months)
- Overall survival(36 months)
- Objective response rate(36 months)
- Duration of response(36 months)
- Disease control rate(36 months)
研究者
Jun Zhang
Chair of Department of Oncology
Ruijin Hospital
研究点 (1)
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