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临床试验 NCT06851819 (TERE) 针对小细胞肺癌广泛期目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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Tislelizumab in Combination with Chemotherapy ± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer. (TERE) II期 64

尚未招募
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临床试验NCT06851819 (TERE)旨在研究治疗，主要针对小细胞肺癌广泛期。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年3月1日开始，预计招募64名患者。该研究由Hebei Medical University Fourth Hospital主导，计划于2029年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年2月28日。
简要概括
The goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide/cisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. 64 Patients with Extensive-Stage Oligometastatic Small Cell Lung Cancer will be randomly divided into the experimental group (tislelizumab combined with chemotherapy and radiotherapy) and the con...显示更多
官方标题

The Efficacy and Safety of Tislelizumab in Combination with Chemotherapy(etoposide/cisplatin )± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer, a Randomized，Controlled , Phase II Clinical Trial.

疾病
小细胞肺癌广泛期
其他研究标识符
  • TERE
  • 2024245
NCT编号
NCT06851819
实际开始日期
2025-03-01
最近更新发布
2025-02-28
预计完成日期
2029-06-30
计划入组人数
64
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性experimental group
Chemotherapy and tislelizumab with Concurrent Chest Radiotherapy or Radiotherapy for oligometastases
放疗
Palliative radiotherapy for oligometastases can be combined with chemoradiotherapy and immunomaintenance therapy period. The investigator determines the number, timing and regimen of oligometastases according to the location, size, symptoms and patient tolerance of oligometastases
immunechemotherapy
Tislelizumab in Combination With Chemotherapy(etoposide/cisplatin )
安慰剂对照placebo group
Chemotherapy and tislelizumab with no radiotherapy
immunechemotherapy
Tislelizumab in Combination With Chemotherapy(etoposide/cisplatin )
主要终点
结果指标度量标准描述时间框架
Progression free survival
Progression free survival
2years
次要终点
结果指标度量标准描述时间框架
Overall survival
Overall survival
2years
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  1. Patients must be ≥ 18 years old;
  2. Signed written informed consent;
  3. Histologically or cytologically confirmed oligometastatic extensive-stage small cell lung cancer (oligometastasis is defined as the number of distant metastatic organs≤ 3, and the number of metastases ≤ 5; The ninth edition of the AJCC/UICC/IASLC TNM Staging Criteria for Lung Cancer (Annex 1), extensive-stage SCLC for any T stage, any N stage, M1a/b/c or T3-4 cannot be included in a tolerable radiotherapy program due to multiple nodules in the lungs or excessive tumor size);
  4. chemotherapy must include a combination of cisplatin and etoposide;
  5. Expected survival≥ 12 weeks;
  6. ECOG score of 0 or 1 (Annex 2);
  7. Weight> 40 kg;
  8. At least 1 lesion (no prior radiotherapy) according to RECIST 1.1 guidelines, with a maximum diameter of ≥10 mm as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must be ≥15 mm in their short axis); And the lesion is suitable for repeated and accurate measurement.
  9. Have not received anti-tumor therapy in the past;
  10. Have adequate organ and bone marrow function,
  11. Echocardiography: Left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%)
  12. Evidence of postmenopausal status in female patients, or negative urine or serum pregnancy test results in premenopausal female patients. A woman is considered menopausal when she stops menstruation for 12 months without an other medical cause.
  13. Within 2 weeks (±1 week) prior to enrollment, the following examinations required for staging must be completed: 1) MRI of the head, CT scan of the chest and upper abdomen, ultrasound of superficial lymph nodes and whole-body ECT; Whole-body PET/CT scan is done if necessary.
  14. Patients with asymptomatic or stable brain metastases after treatment are allowed to enroll, and patients are required to do not need glucocorticoid therapy or discontinue glucocorticoids within 3 days before the first study dose.

  1. Personnel involved in the design and/or conduct of this study.
  2. Previous receipt of investigational drug in this study.
  3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
  4. There are medical contraindications to etoposide-platinum-based chemotherapy.
  5. History of thoracic radiotherapy prior to systemic therapy.
  6. Concomitant administration of any chemotherapy, biologics, or hormonal therapy for cancer treatment. Hormone therapy for noncancer-related conditions, such as hormone replacement therapy, is acceptable.
  7. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose.
  8. History of allogeneic organ transplantation.
  9. Patients who have been cured of aplastic anemia or other blood diseases and patients who have undergone stem cell transplantation.
  10. Have an autoimmune paraneoplastic syndrome (PNS) that requires systemic therapy (systemic steroids or immunosuppressants) or have clinical symptoms suggestive of an exacerbation of PNS.
  11. Active or previously documented autoimmune or inflammatory disease (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, nephrotic syndrome or nephritis, Wegener syndrome \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis and uveitis, etc.\]). The following exceptions are made to this criterion: patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., after Hashimoto syndrome) who are stable after receiving hormone replacement therapy; Any chronic skin condition that does not require systemic therapy; Patients with no active disease in the past 3 years may be included in the study after discussion with the study physician; Patients with celiac disease who can be controlled by diet alone.
  12. Uncontrolled intercurrent illness including, but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social problems that may limit compliance with study requirements, recent (within 3 months) new cerebral infarction/intracerebral hemorrhage, psychiatric/social problem conditions that result in a significantly increased risk of AEs, or affect the subject's ability to provide written informed consent.
  13. History of another primary malignancy, with the following exceptions: malignancy treated with curative intent, no known active disease for 5 years ≥ prior to the first dose and a low risk of potential recurrence; adequately treated non-melanoma skin cancer or lentigo maligna nevus with no evidence of disease; Carcinoma in situ that has been adequately treated and has no evidence of disease.
  14. History of leptomeningeal carcinoma.
  15. History of active primary immunodeficiency.
  16. Active infection, including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings, and TB examination consistent with local clinical practice), hepatitis B (known to be HBV surface antigen \[HbsAg\] positive), hepatitis C, or human immunodeficiency virus (HIV1/2 antibody positive). Patients with prior HBV infection or who have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Patients who are positive for hepatitis C virus (HCV) antibodies are eligible only if they are negative for HCV RNA polymerase chain reaction.
  17. Female patients who are pregnant or lactating.
  18. Those who are considered inappropriate by the investigator to participate in this study.
Hebei Medical University Fourth Hospital logoHebei Medical University Fourth Hospital
研究责任方
Wenbin SHEN, 主要研究者, MD, Hebei Medical University Fourth Hospital
研究中心联系人
联系人: Wenbin Shen, 8615831183879, [email protected]
联系人: Xuehan Guo, 8613833156327, [email protected]
1 位于 1 个国家/地区的研究中心

Hebei

Hebei Medical University Fourth Hospital, Shijiazhuang, Hebei, 050000, China
Xuehan Guo, 联系人, 8613833156327, [email protected]