A Phase II Study of Second-line Chemotherapy Combined With Endostatin for Recurrent/Metastatic Head and Neck Epithelial Tumors That Cannot be Re-irradiated or Re-operated After Fist-line Platinum-based Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.
详细描述
The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. New agent for second-line treatment of recurrent and/or metastatic head and neck tumors is urgently needed. Recombinant human endostatin is an anti-angiogenetic target drug, which has been demonstrated a good efficacy for NSCLC. Studies about recombinant human endostatin in head and neck cancer mainly focus on NPC. And phase I study of endostatin combined with chemotherapy and/or radiotherapy for NPC showed a promising results.
This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old，<70 years old.
- •Histopathology confirmed head and neck epithelial tumors, ie. Squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, et al.
- •Relapse or metastasize after fist-line platinum-based chemotherapy，and the lesions cannot be re-irradiated or re-operated.
- •At least one measurable lesion (RECIST 1.1 version).
- •Life expectancy ≥ 6 months.
- •Adequate bone function: WBC≥3.0x109/L, ANC≥1.5 x109/L, HB≥90g/L, PLT≥100 x109/L. AST, ALT, Creatinine, urea nitrogen<1.25 ULN, normal coagulation function parameters.
排除标准
- •Malignant melanoma, lymphoma, other tumors from mesenchymal tissues.
- •Second primary malignant tumors.
- •Contraindications of chemotherapy: severe infections, significant cardiovascular disease, symptomatic arrythmia, uncontrolled diabetes mellitus, et al.
- •HIV infection, untreated chronic hepatitis B infection or carriers of HBV DNA copies >500IU/ml, active hepatitis C patients.
- •Uncontrolled hypertension.
- •Hemorrhagic tendency.
- •Epileptic seizure.
- •History of progression after anti-angiogenic target treatment.
- •History of allergy to recombinant human endostatin.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- •Receiving treatment of other clinical trials.
研究组 & 干预措施
Second-line chemotherapy combined with Endostar
Second-line chemotherapy+Endostar
干预措施: second-line chemotherapy (Drug)
Second-line chemotherapy combined with Endostar
Second-line chemotherapy+Endostar
干预措施: Recombinant human endostatin (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months
include complete remission, partial remission, and stable disease
次要结局
- Objective Response Rate (ORR)(From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months)
- Progress Free Survival (PFS)(From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
- Overall Survival (OS)(From the date of first drug administration until the date of death, assessed up to 36 months)
研究者
Sun Yan
MD, Professor, Chief of Head and Heck Group of Radiotherapy Department, Peking University Cancer Hospital, Peking University
Peking University