PACTR202201585469592尚未招募3 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNRESECTABLE ESOPHAGEAL SQUAMOUS CELL CARCINOMA WHOSE CANCERS HAVE NOT PROGRESSED FOLLOWING DEFINITIVE CONCURRENT CHEMORADIOTHERAPY
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry:
- •Signed Informed Consent Form
- •Age 18 years at time of signing Informed Consent Form
- •Ability to comply with the study protocol, in the investigator’s judgment
- •ECOG Performance Status of 0 or 1
- •Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
- •Stage IIIVA per American Joint Committee on Cancer/Union for International CancerControl, 8th edition, unresectable locally advanced disease (medically or surgery is declined) prior to dCRT. dCRT treatment according to regional oncology guidelines (Such as National Comprehensive Cancer Network [NCCN; see Appendix 10 for recommended treatment], European Society for Medical Oncology [ESMO], Chinese Society of Clinical Oncology [CSCO], etc.) for esophageal cancer and with the following criteria:
- •Patients with inoperable cancer must have received at least 2 cycles of platinum-based chemotherapy and radiation therapy consistent with definitive treatment (5064 Gy) without evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-dCRT) prior to randomization.
- •Patients with cervical esophageal squamous cell carcinoma may receive higher radiation dose (50-66 Gy), as per local oncology guidelines.
- •Randomization into the study must occur within 184 days after the last dose of radiation therapy.
- •Use of herbal therapies/traditional Chinese medicines with anti-cancer activity intended to treat the disease under the study must be discontinued prior to randomization.
- •Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens 12 months old, collected prior to initiation of dCRT in either paraffin blocks (preferred over slides) or approximately 10 15 slides (15 slides preferred) containing unstained, freshly cut, serial sections (of the 10-15 slides, 5 are for the stratification PD-L1 testing). The number of slides provided may also be governed by local regulations (e.g., Human Genetic Resources Administration of China)
- •Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained after the last dose of chemoradiotherapy and within 14 days prior to randomization.
- •Negative HIV test at screening
- •Patients without hepatitis B virus (HBV) infection or for patients with a positive hepatitis B surface antigen (HBsAg) test and/or a positive total hepatitis B core antibody (HBcAb) test in the absence of a positive hepatitis B surface antibody (HBsAb) test at screening: HBV DNA less than 500 IU/mL
- •Patients with detectable HBV DNA should be managed per institutional guidelines. Initiation of anti-HBV therapy should be 14 days prior to initiation of study treatment, and patients should be willing to continue anti-HBV therapy for the duration of study treatment, and longer per institutional guidelines.
- •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, antiPD-1, antiPD-L1 and anti-TIGIT therapeutic antibodies
- •Any unresolved toxicity of NCI CTCAE Grade more than or equal to 2 from the prior chemoradiation therapy. Patients with irreversible and manageable hearing loss are eligible.
- •Evidence of complete esophageal obstruction not amenable to treatment
- •Histology consistent with small cell esophageal carcinoma, esophageal adenocarcinoma, or mixed carcinoma
- •High risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula, or primary tumor invasion of the great vessels or trachea
- •Prior esophagectomy
- •Positive Epstein-Barr virus (EBV) viral capsid antigen IgM test at screening. An EBV polymerase chain reaction (PCR) test should be performed as clinically indicated to screen for active infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded.
- •Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
- •Uncontrolled or symptomatic hypercalcemia
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Active tuberculosis
- •Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment
- •History of malignancy other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •Patients who received endoscopic mucosal resection or dissection for superficial mucosal cancers other than esophageal squamous cell carcinoma (ESCC) within 2 years prior to screening are eligible for the study.
- •Patients with illness or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures
- •Severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
研究者
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