NCT06356675尚未招募4 期
A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine0 个研究点目标入组 33 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 主要终点
- objective response rate
研究概览
简要总结
Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes.
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
- •voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures;
- •age of 18-75 years old (including boundary value), regardless of gender;
- •Pathologically confirmed locally advanced, metastatic non-small cell lung cancer (NSCLC), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Patients with non-squamous non-small cell lung cancer should exclude known EGFR mutation or ALK gene rearrangement.
- •patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy;
- •patients with tumor response of CR/PR/SD after at least one first-line immunotherapy;
- •Subjects' ECOG PS score was 0-1 (including boundary value);
- •Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria).
- •predicted survival time ≥6 months;
排除标准
- •Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs;
- •central lung cancer with large blood vessel invasion;
- •patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; Patients with bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug;
- •hemoptysis > 50ml/d;
- •inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction;
- •Poorly controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg)
- •other known malignant tumors that are developing or require active treatment;
- •Currently participating or has participated in the clinical research of other drugs;
- •interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy
研究组 & 干预措施
treatment group
Experimental
Tislelizumab 200mg iv D1+anlotinib(12mg D1-12)
干预措施: Tislelizumab (Drug)
treatment group
Experimental
Tislelizumab 200mg iv D1+anlotinib(12mg D1-12)
干预措施: Anlotinib (Drug)
结局指标
主要结局
objective response rate
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
The rate of tumor shrinkage reached 30% at least .including part reponse and complete response
次要结局
- progression free survival time(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- over survival time(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to18 months)
- disease control rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)
- safety including any grade adverse events(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months)
研究者
Linzhu Zhai
professor of medicine，Deputy Director of Department of Radiotherapy, Oncology Center
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
相似试验
招募中
2 期
Tislelizumab Plus Lenvatinib in Stage III-IV RCCAdvanced Kidney CancerNCT05485883Tianjin Medical University Second Hospital20
Unknown
1 期
Study of Chemotherapy and PD-1 Inhibitor Combination With Anti-angiogenesis to Treat Elderly Lung CancerNon-Small Cell Lung CancerNCT05273814Tianjin Medical University Cancer Institute and Hospital30
Unknown
2 期
Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal CancerColo-rectal CancerGastric CancerNCT04777162Peking University40
进行中（未招募）
不适用
Tislelizumab Combined With Chemotherapy in First-line Treatment of AGCTislelizumabChemotherapyFirst-lineGastric Cancer Stage IVNCT06034964Cancer Institute and Hospital, Chinese Academy of Medical Sciences60
尚未招募
2 期
Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell CarcinomaESCCNCT05547828The First Affiliated Hospital of Xinxiang Medical College20