NCT03855384Unknown3 期
Multicenter, Randomized, Double-blind, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of TQB2450 Plus Chemotherapy（Cisplatin or Carboplatin+ 5-Fluorouracil (5-FU) ） Versus Placebo Plus Chemotherapy as First-Line Treatment in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma（R/M SCCHN）
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed head and neck squamous cell carcinoma ，primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
- •No indications of local radical therapy for recurrence/metastasis head and neck squamous cell carcinoma.
- •At least one measurable lesion（ based on RECIST1.1）.
- •Can provide tissue for PD-L1 biomarker analysis: A newly obtained biopsy is preferred but an archival sample is acceptable.
- •Tumors express PD-L1,and PD-L1 expression on at least 1% of tumour cells .
- •18 years and older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy of at least 3 months.
- •The main organs function are normally, the following criteria are met:
- •routine blood tests：hemoglobin（Hb）≥90g/L（no blood transfusion and blood products within 14 days）；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
- •Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)（Gilbert syndrome patients，≤3×upper limit of normal (ULN)）； calculated creatinine clearance（CrCl）≥60mL/min（Creatinine clearance criteria for subjects treated with cisplatin）or CrCl≥50mL/min（Creatinine clearance criteria for subjects treated with carboplatin）(Application of Standard Cockcroft-Gault Formula).
- •Coagulation function: activated partial thromboplastin time (aPTT) 、 international normalized ratio (INR) 、prothrombin time（PT）≤ 1.5×upper limit of normal (ULN).
- •left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
- •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(Such as intrauterine devices , birth control pills or condoms) ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening（Within 7 days before the start of the study）, the women who blood / urine results were positive.
- •Understood and signed an informed consent form.
排除标准
- •Received systemic chemotherapy, but not chemotherapy for locally advanced disease as part of multimodality therapy (this treatment must be completed more than 6 months after informed consent).
- •Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- •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.
- •Patients who have received cetuximab treatment within 6 moths before randomization.
- •Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.
- •Known untreated central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- •Has neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
- •Previously had a severe hypersensitivity reaction to treatment with study drug or has a known sensitivity to any component of drug , including Severe hypersensitivity reaction≥3 grades (NCI CTCAEv5.0 )to monoclonal antibody 、fluorouracil、 carboplatin or cisplatin-related compounds.
- •Active autoimmune disease that may worsen with the administration of an immunostimulant. Patients with type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism that do not require immunosuppression therapy are excluded.
- •Immunosuppressive drugs were used at randomization,except that:
- •Intranasal, inhaled, topical steroid or topical steroid injection (e.g. intra-articular injection)
- •Physiological doses of systemic corticosteroids (a dose of ≤ 10 mg daily prednisone (or equivalent) )
- •Preadministration of steroids for hypersensitivity reactions (e.g., preadministration of CT scans)"
- •Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension,acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis.
- •Has any other active infection requiring systemic therapy,including patients with active tuberculosis.
- •Unstable pleural effusion, pericardial effusion or ascites.
- •Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina.
- •Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history.
- •Virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
- •a. HBsAg positive and HBV DNA positive (≥1000 copies /mL); b. HCV antibody and HCV-RNA positive(The result is greater than the detection limit of the analytical method).
- •Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks before randomization.
- •18.Has received a live-virus vaccination within 4 weeks before randomization ,allowing received seasonal flu vaccines without live viruses.
- •Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
- •Investigator judges that the patient is not eligible to join the study.
研究组 & 干预措施
TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
Experimental
干预措施: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU) (Drug)
placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
Placebo Comparator
干预措施: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU) (Drug)
结局指标
主要结局
OS
时间窗: up to 72 weeks
Overall survival
次要结局
- DOR(up to 72 weeks)
- PFS(up to 24 weeks)
- DCR(up to 24 weeks)
研究者
研究点 (1)
Loading locations...
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