Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.
详细描述
The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without durgguable targets. The efficacy and safety of these regimens were evaluated.
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
- •Malignant solid tumors diagnosed histologically;
- •Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment;
- •Expected survival ≥ 1 month;
- •ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
排除标准
- •Patient still has standard treatment therapy based on NCCN guidance;
- •Patient can not comply with research program requirements or follow-up;
研究组 & 干预措施
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Gefitinib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Erlotinib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Afatinib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Trastuzumab (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Oxazolidine (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Olaparib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Everolimus (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Cabozantinib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Vemurafenib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Dabrafenib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: Palbociclib (Drug)
Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.
干预措施: PD-1/L1 inhibitor plus anti-angiogenic agent (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
次要结局
- Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months)
- Adverse Effect(Through study completion, an average of 1 months)
- Progress Free Survival(Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months)
研究者
Baodong Qin
Clinical Professor
Shanghai Changzheng Hospital