NL-OMON52872招募中2 期
TGF-β And PDL-1 inhibition with Bintrafusp alfa in Esophageal Squamous Cell carcinoma combined with chemoradiation TheRapY (TAPESTRY) - TAPESTRY
Medische oncologie0 个研究点目标入组 67 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
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
- 18 至 99（—）
入选标准
- •- Histologically proven squamous cell carcinoma of the esophagus or gastro
- •esophageal junction.
- •- Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic
- •Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen.
- •Patients with M1 disease solely on the basis of supraclavicular metastasis are
- •eligible. Patients with resectable tumors refusing radical surgery or
- •inoperable patients due to comorbidity are eligible.
- •- Locoregional recurrences without distant metastasis after surgery alone or
- •endoscopical resection
- •- Locoregional recurrences without distant metastasis after neoadjuvant
- •chemoradiation + resection or definitive chemoradiation outside the previously
- •irradiated area, provided that full dose of radiation can safely be delivered.
- •- Tumors that cannot be passed with an endoscope for endoscopic ultrasound are
- •eligible if all other criteria are fulfilled.
- •- If the tumor extends below the gastroesophageal (GE) junction into the
- •proximal stomach, the bulk of the tumor must involve the esophagus or GE
- •- Age >= 18.
- •- ECOG performance status 0-2
- •- Adequate hematological, renal and hepatic functions.
- •- Written, voluntary informed consent
- •- Patients must be accessible to management and follow-up in the treatment
排除标准
- •- Past or current history of malignancy other than entry diagnosis interfering
- •with prognosis of esophageal cancer.
- •- Patient with tracheo-esophageal fistula or extension into the mucosal layer
- •of the trachea, highly at risk to develop fistula. Thus, tumor extension to the
- •trachea is allowed, but not through the trachea.
- •- Patient with aortal involvement with high risk of bleeding or developing a
- •- Patients with pathological lymph nodes at both supraclavicular and truncus
- •coeliacus level.
- •- Pregnancy (positive serum pregnancy test), planning to become pregnant, and
- •- Patient (male or female) in the reproductive age is not willing to use highly
- •effective methods of contraception (per institutional standard) during
- •treatment and for 6 months (male or female) after the end of treatment.
- •- Previous chemotherapy, radiation and/or treatment with checkpoint inhibitors
- •for the currently present esophageal tumor.
- •- Previous chemotherapy and/or treatment with targeted agents and/or checkpoint
- •inhibitors for other forms of cancer within the last six months.
- •- Previous radiation to the mediastinum precluding full dose radiation of the
- •currently present esophageal tumor.
- •- Presence of an esophageal stent.
- •- History of bleeding diathesis or major bleeding event (grade >= 2) in the
- •month prior to first dose of trial treatment.
- •- Current use of direct oral anticoagulants or coumarins.
- •- Clinically significant cardiovascular disease precluding safe treatment with
- •chemoradiation.
- •- Evidence of pulmonary fibrosis and/or clinically significant impairment of
- •lung function precluding safe treatment with chemoradiation. In case of doubt
- •about pulmonary function, a lung function test should be performed and, in case
- •of abnormalities, discussed with the principle investigator.
- •- Serious underlying medical condition which would impair the ability of the
- •patient to receive the planned treatment, including prior allergic reactions to
- •drugs containing cremophor, such as teniposide or cyclosporine.
- •- Mental status that would prohibit the understanding and giving of informed
- •- Inadequate caloric- and/or fluid intake despite consultation of a dietician
- •and/or tube feeding.
- •- Has an active autoimmune disease that has required systemic treatment in past
- •2 years (i.e. with use of disease modifying agents, corticosteroids, or
- •immunosuppressive drugs). Replacement therapy (e.g., thyroxine for patients
- •with a history of autoimmune-related hypothyroidism, insulin for patients with
- •type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for
- •adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
- •treatment. Patients with vitiligo with dermatological manifestations only are
- •eligible to enter the study.
- •- Diagnosis of HIV unless stable on antiretroviral therapy for at least 4
- •weeks, no evidence of multi-drug resistance, viral load of < 400 copies/ml and
- •CD4+ T-cells >= 350 cells/µl.
- •- Active HBV/HCV. Participants on a stable dose of antiviral therapy with
- •HBV/HCV viral load below the limit of quantification are eligible.
- •- A diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10
- •mg/day prednisone or equivalent) or any other form of immunosuppressive therapy
- •within 7 days prior to the first dose
研究者
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