Tislelizumab Combined With Recombinant Human Endostatin Injection Plus Chemotherapy in Unresectable Stage III NSCLC: a Prospective, Single-arm, Multicenter Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Surgical resection rate
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- •Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, and non-squamous cell carcinoma with unknown driver gene status;
- •Previous treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.
- •Patients with large cell neuroendocrine carcinoma (LCNEC) components and non-small cell lung cancer with mixed small cell components.
- •Patients received other approved systemic immunomodulators (including, but not limited to, interferon, interleukin 2, tumor necrosis factor, thymus pentapeptide, and thymofasin) within 4 weeks prior to initial administration.
- •In the course of treatment, researchers determined that patients' tumors were more likely to invade important blood vessels and cause fatal bleeding.
- •Clinically significant hemoptysis (more than 50ml of hemoptysis per day), or clinically significant bleeding symptoms or significant bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occulted blood ++ or above baseline, or vasculitis) within 3 months before the study.
- •Any Chinese herbs used for cancer control were used within 14 days prior to the first administration of the study drug.
- •Have received live vaccine within 30 days before the first dose. Including but not limited to the following: mumps, rubella, measles, varicella/shingles (chickenpox), yellow fever, rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed); Live or attenuated vaccine is expected to be required during the study period or within 5 months after the last dose.
- •For any condition requiring systemic treatment with corticosteroids (prednisone or equivalent >10 mg/ day) or other immunosuppressive agents within 14 days prior to the first administration of the study drug, the investigator assessed the patient as having an impact on the study treatment.
- •Active autoimmune diseases requiring systemic treatment in patients assessed by the investigator as having an impact on investigational treatment.
- •Patients with interstitial lung disease, non-infectious pneumonia, or other diseases that are not under control, including diabetes, pulmonary fibrosis, acute lung disease, etc., that the investigators have assessed as having an impact on the study treatment.
- •Patients with a history of major diseases or clinical manifestations that may affect the function of organ systems and are assessed by the investigator as having implications for the study and treatment.
- •Study severe chronic or active infections (including tuberculosis) requiring systemic antimicrobial, antifungal, or antiviral treatment ≤14 days before the first administration of the drug.
- •Uncontrolled active hepatitis B (defined as positive HBV surface antigen [HBsAg] test results during screening and HBV-DNA test values higher than the upper limit of normal values in the laboratory of the research center; (Participants with HBV-DNA levels < 500 IU/mL within 28 days prior to enrollment, who have received local standard antiviral therapy for at least 14 days and who are willing to continue antiviral therapy during the study period may be enrolled); Subjects with active hepatitis C (defined as positive HCV surface antibody [HCsAb] test results during screening, positive HCV-RNA);
- •Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- •Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
- •Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to treatment;
- •Concurrent participation in another therapeutic clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
- •Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
研究组 & 干预措施
Participant Group/Arm A
Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment during preoperative period, every 3 weeks once for 4 cycles at most.
After neoadjuvant therapy, Patients evaluated for MDT who can be surgically resected will be placed in the surgical group for surgical excision.
Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy.
After surgery, participants will receive adjuvant therapy with tislelizumab combined with recombinant human endostatin injection every 3 weeks until disease progression or postoperative adjuvant therapy for 1 year.
干预措施: surgery (Procedure)
Participant Group/Arm B
Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment , every 3 weeks once for 4 cycles at most. After neoadjuvant therapy, Patients evaluated by MDT as unresectable will be placed in the standard treatment group, where the investigator will select the standard treatment regimen determined by the MDT discussion.
干预措施: Standard Treatment (Other)
结局指标
主要结局
Surgical resection rate
时间窗: From enrollment to the end of surgery
Proportion of patients who underwent surgical resection after induction therapy
次要结局
- Objective response rate (ORR)(prior to surgery)
- 1 years Progression-Free Survival (PFS)(1 years after randomization)
- 1 years overall survival rate (OS)(1 years after randomization)
- Event-Free Survival(EFS)(Up to 2years)
- Overall Survival(3 years)
- 1 years event free survival (EFS)(1 years)
- Pathological Complete Response (pCR) Rate(1 month after surgery)
- Progression-Free Survival (PFS)(Up to 12 months)
- Safety and Tolerability(Up to 3 years)
- Major Pathological Response (MPR) Rate(1 month after surgery)
- R0 Resection Rate(1 month after surgery)
研究者
Hua Zhang
Head of thoracic surgery
Shandong Public Health Clinical Center