PER-094-20招募中1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY OF NEOADJUVANT-ADJUVANT DURVALUMAB AND FLOT CHEMOTHERAPY FOLLOWED BY ADJUVANT DURVALUMAB IN PATIENTS WITH RESECTABLE GASTRIC AND GASTROESOPHAGEAL JUNCTION CANCER (GC/GEJC) (MATTERHORN)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
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
入选标准
- •1Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- •3Age ≥18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- •4Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (ie, radical-surgery eligible; Stage II or higher [>T2 N0-3 M0 or T0-4 N1-3 M0] per AJCC 8th edition). GEJC includes Siewert* type 2 and 3 tumor. Siewert* type 1 tumor is also eligible as long as the patient is intended to be treated in the same way as for Siewert type 2 and 3 tumors.
- •(a)Per the judgment of the Investigator, patient must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
- •(b)At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon (see Section 6.1.3 regarding surgical plan).
- •(c)No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.
- •5World Health Organization (WHO)/ECOG performance status (PS) of 0 or 1 at enrollment
排除标准
- •1Patients with peritoneal dissemination (including tumor cells in peritoneal fluid) or distant metastasis
- •2Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
- •3History of allogeneic organ transplantation.
- •4Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- •(a)Patients with vitiligo or alopecia
- •(b)Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- •(c)Any chronic skin condition that does not require systemic therapy
- •(d)Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor
- •(e)Patients with celiac disease controlled by diet alone
研究者
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