ITMCTR1900002567招募中未知
Multicenter, open, single-arm Clinical Study to Evaluate the Efficacy and Safety of Sintilimab Plus Chemotherapy (Cisplatin or Carboplatin+ Paclitaxel) as First-Line Treatment in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M SCCHN)
Shanghai East Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Histologically- or cytologically-confirmed head and neck squamous cell carcinoma and no indications of local radical therapy.
- •2. At least one measurable lesion (based on RECIST1.1).
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •4. Life expectancy of at least 3 months.
- •5. Can provide at least 20 pathological sections.
- •6. Adequate organs function.
- •7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study; For female subjects only, not pregnant or breastfeeding, and result of blood / urine pregnancy test (Within 7 days before the start of the study) should be negative.
- •8. Be willing to sign an informed consent form.
排除标准
- •1. The primary tumor is squamous cell carcinoma of nasopharynx or skin.
- •2. Received systemic chemotherapy.
- •3. Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for local advanced HNSCC.
- •4. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •5. Diagnosed within 5 years or currently has other primary malignancy with the exception of cured carcinoma in situ of the cervixintramucosal carcinoma of gastrointestinal tractbreast and non-melanoma skin cancers and superficial bladder tumors.
- •6. Known untreated central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- •7. Has peripheral neuropathy that is >= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- •8. Previously had a severe hypersensitivity reaction to treatment with study drug or has a known sensitivity to any component of study drug, including severe hypersensitivity reaction >= Grade 3 (CTCAE v5.0) to monoclonal antibody, paclitaxel, carboplatin or cisplatin-related compounds.
- •9. Has active autoimmune disease that may worsen with the administration of an immunostimulant.
- •10. Use immunosuppressive drugs, except that:
- •11. History (current and past) of interstitial lung disease or non-contagious pneumonia with the exception of local interstitial pneumonia induced by radiotherapy;
- •12. Uncontrolled systemic diseases including diabetes, hypertension etc.
- •13. Any other active infection requiring systemic therapy, including active tuberculosis.
- •14. Uncontrolled pleural effusion, pericardial effusion or ascites.
- •15. Significant cardiovascular diseases such as heart failure of New York Heart Academy (NYHA) Grade 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval >= 480 ms) or unstable Angina.
- •16. History of immunodeficiency, including HIV positive or other, congenital / acquired immunodeficiency disease, or history of organ transplant.
- •17. Virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
- •a) HBsAg positive and HBV DNA titer >= 1000 copies /mL;
- •b) HCV antibody positive and HCV-RNA titer greater than the lower limit of detection.
- •18. Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the enrollment.
- •19. Receipt of any live vaccine within 4 weeks prior to the enrollment, but seasonal flu vaccines without live viruses are allowed.
- •20. Receipt of any investigational agent or used an investigational device within 4 weeks prior to the enrollment.
- •21. Any other condition that make the subject unfit to the study according to investigators judgement.
研究者
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