NCT05472467Unknown2 期
Camrelizumab Combination With SBRT and Concurrent Chemotherapy Treated Stage IV Oligometastatic Non-small Cell Lung Cancer ，a Single-arm, Single-center, Exploratory Clinical Study（IMCORT-2）
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年12月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer
详细描述
This study evaluated the effectiveness and safety of Camrelizumab combination with SBRT and concurrent chemotherapy treated stage IV oligometastatic non-small cell lung cancer.
The primary endpoint is ORR. Secondary points contains：PFS、OS、DCR、Qol.
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
- 是
入选标准
- •patients voluntarily enrolled in this study and signed the informed consent form (ICF).
- •Good compliance and cooperation with follow-up.
- •age: 18 to 75 years, both sexes.
- •ECOG PS: 0 to 1 score.
- •patients with non-small cell lung cancer clearly diagnosed by pathology, with measurable tumor lesions (oligometastases ≥10 mm in length, meeting mRECIST1.1 criteria).
- •subjects with clinical stage IV according to the 8th edition of the Clinical Oncology TNM staging Stage IV (≤5 oligometastases, ≤3 metastatic organs, and measurable metastases) non-small cell lung cancer patients according to the 8th edition of TNM staging.
- •patients with stage IV clinical stage (number of oligometastases ≤ 5, metastatic organs ≤ 3, and measurable metastases) non-small cell lung cancer
- •vital organ function meets the following requirements (no blood components and cell growth are allowed 2 weeks prior to the start of study treatment) (No blood components or cell growth factors are allowed 2 weeks prior to the start of study treatment).
- •(1) Routine blood tests must meet the following requirements.
- •absolute neutrophil count (ANC) ≥ 1.5 x 109
- •Hemoglobin (HB) ≥ 9 g/dL.
- •Platelets (PLT) ≥ 100×109 /L.
- •serum albumin (ALB) ≥ 2.8g/dL. (2) Biochemical examination shall comply with.
- •a) total bilirubin (TBIL) ≤ 1.5 ULN. b) ALT, AST ≤ 2.5 UILN (if liver function abnormalities due to liver metastases, then ≤ 5 ULN) b) ALT, AST ≤ 2.5 UILN (≤ 5 ULN if liver function abnormalities are due to liver metastasis).
- •c) serum creatinine sCr ≤ 1.5 ULN, endogenous creatinine clearance c) serum creatinine sCr ≤ 1.5 ULN and endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula).
- •expected survival ≥ 3 months.
- •the patient is judged by the investigator to be amenable to treatment with kallikreinumab
- •the patient has no autoimmune disease.
- •the patient has not received prior treatment with PD-1/PD-L1 inhibitors.
- •tissue or plasma genetic testing for common lung cancer driver genes such as EGFR, ALK, ROS, RET, HER2, MET, BRAF negative, or no accessible targeted drugs or who are intolerant to targeted drug therapy.
- •Female subjects of childbearing potential should receive their first study drug administration within
- •Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to the first study drug administration and demonstrate
- •Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to the first dose of study drug and be willing to use validated methods during the trial until 3 months after the last administration of cariolizumab. Male subjects whose partners are women of childbearing potential should use an effective method of contraception for the duration of the trial and for 3 months after the last administration of cariolizumab. Male subjects whose partners are women of childbearing potential should use an effective method of contraception during the trial and for 3 months after the last administration of carreliximab
排除标准
- •patients who do not meet the inclusion criteria for type of pathology and site of primary focus.
- •with diffuse brain metastases and meningeal metastases
- •have any active autoimmune disease or a history of autoimmune disease such as inter stromal pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy).
- •may be included after normalization of hormone replacement therapy).
- •patients with asthma requiring medical intervention with bronchodilators
- •patients with uncontrolled cardiac clinical symptoms or disease, such as. (1) NYHA class II or higher heart failure. (2) Unstable angina pectoris. (3) Myocardial infarction within 1 year. (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- •active infection or unexplained fever of >38.5°C (0.5 mg/kg) during screening or before the first dose Fever >38.5°C (in the judgment of the investigator, subjects with fever due to tumor fever can be enrolled).
- •a known history or evidence of interstitial lung disease or active non-infectious pneumonia
- •have a congenital or acquired immune deficiency (e.g., HIV-infected), active Hepatitis B (HBV-DNA ≥ 104 copies/mL) or Hepatitis C (Hepatitis C antibody positive and HCV-RNA above the lower limit of detection for the assay).
- •prior treatment with other PD-1 monoclonal antibodies or other immunotherapy against PD-1/PDL1
- •known hypersensitivity to macromolecular protein agents, or to any of the components of kareolizumab sensitization.
- •Requirement for corticosteroids (>10 mg/day, prednisone) within 14 days prior to first administration of study drug.
- •10 mg/day, prednisone efficacy dose) or other immunosuppressive agents for systemic therapy within 14 days prior to the first Subjects on systemic therapy with corticosteroids (> 10 mg/day, prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to first study drug administration. In the absence of active autoimmune disease In the absence of active autoimmune disease, inhaled or topical steroids and adrenaline at doses >10 mg/day, prednisone efficacy dose are allowed.
- •Adrenocorticosteroid replacement at efficacious doses of prednisone.
- •have received an antitumor monoclonal antibody (mAb) within 4 weeks prior to the first administration of study drug (mAb) within 4 weeks prior to the first administration of study drug, or adverse events from previously received drugs have not Recovery (i.e., ≤ grade 1 or at baseline level). Note: Occurrence of ≤ grade 2 neuropathy or ≤ grade 2 alopecia.
- •Note: Subjects with ≤ grade 2 neuropathy or ≤ grade 2 alopecia are excluded if the subject has undergone major surgery.
- •If the subject has undergone major surgery, the toxic effects and/or complications of the surgical intervention must be adequately addressed prior to initiation of treatment.
- •Subjects who have undergone major surgery must have recovered sufficiently from the toxic effects and/or complications of their surgical intervention prior to initiation of treatment.
- •the subject is participating in another clinical study
- •the subject has received a live vaccine within 4 weeks prior to the first administration of the study drug and is allowed to receive injectable
- •Receipt of inactivated viral vaccine for seasonal influenza, by injection, but not receive live attenuated influenza vaccine administered via intranasal route.
- •subjects who, in the judgment of the investigator, have other factors that may force them to terminate the other factors that, in the judgment of the investigator, may force him or her to terminate the study, such as other serious illnesses (including mental illness) requiring comorbid treatment, severely abnormal laboratory test values, family or social factors that circumstances that may affect the safety of the subject or the collection of trial data.
- •other circumstances that, in the judgment of the investigator, make inclusion in this study inappropriate
研究组 & 干预措施
Immunotherapy combined with Stereotactic Body Radiation Therapy
Experimental
- Camrelizumab： 200mg IV Q3W
- Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles.
Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。
干预措施: Camrelizumab (Drug)
Immunotherapy combined with Stereotactic Body Radiation Therapy
Experimental
- Camrelizumab： 200mg IV Q3W
- Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles.
Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。
干预措施: stereotactic body radiation therapy (Radiation)
Immunotherapy combined with Stereotactic Body Radiation Therapy
Experimental
- Camrelizumab： 200mg IV Q3W
- Chemotherapy：Squamous carcinoma: docetaxel 60 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6 d1, 21 days for one cycle, up to 4 cycles.
Non-squamous carcinoma: pemetrexed 500 mg/m2, d1 + cisplatin 25 mg/m2, d1-3 or carboplatin AUC=4-6, d1,21 days for one cycle, up to 4 cycles. 3. Stereotactic Body Radiation Therapy(SBRT) for Oligometastatic the total dose 35Gy/5f(7.0Gy/f,5f per week)。
干预措施: Chemotherapy (Drug)
结局指标
主要结局
ORR
时间窗: up to 3 years
Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission.
次要结局
- PFS(up to 3 years)
- OS(up to 3 years)
- HRQoL(up to 3 years)
研究者
LI TAO
Section Head
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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