NCT04592913进行中（未招募）3 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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 958
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
详细描述
This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 200 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- •Patients must undergo radical surgery.
- •No prior anti-cancer therapy for the current malignancy.
- •World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- •Adequate organ and marrow function.
- •Availability of tumor sample prior to study entry.
- •Must have a life expectancy of at least 24 weeks.
排除标准
- •Patients with peritoneal dissemination or distant metastasis.
- •Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- •Contra-indication to any of the study drugs.
- •History of allogeneic organ transplantation.
研究组 & 干预措施
Arm B
Placebo Comparator
placebo product and FLOT chemotherapy
干预措施: FLOT chemotherapy (Drug)
Arm A
Experimental
Durvalumab and FLOT chemotherapy
干预措施: Durvalumab (Drug)
Arm A
Experimental
Durvalumab and FLOT chemotherapy
干预措施: FLOT chemotherapy (Drug)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.
次要结局
- To compare Arm A relative to Arm B on pathological complete response (pCR) rate(Up to 5 years)
- To compare Arm A relative to Arm B on overall survival (OS)(Up to 5 years)
研究者
研究点 (1)
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相关资讯
MATTERHORN Final OS: Perioperative Durvalumab Plus FLOT Cuts Death Risk 22% in Resectable Gastric/GEJ Cancer- Final overall survival results from the phase 3 MATTERHORN trial show perioperative durvalumab plus FLOT reduced the risk of death by 22% versus placebo plus FLOT.
- At a median follow-up of 43 months, 69% of durvalumab-treated patients were alive at three years versus 62% in the control group.
- The overall survival benefit was consistent across most subgroups, including regardless of PD-L1 expression status, and appeared more pronounced in node-positive disease.
- Based on MATTERHORN, the EMA approved durvalumab with chemotherapy as the first and only perioperative immunotherapy for early-stage gastric or gastroesophageal junction cancer.6 days agoctDNA-Guided Adjuvant Therapy in Colorectal Cancer: BESPOKE CRC and the Promise of Next-Generation Drugs- Nicholas Hornstein, MD, PhD, highlights that positive ctDNA after colorectal cancer surgery signals an overwhelming likelihood of recurrence despite clean imaging and normal CEA.
- The BESPOKE CRC study is reshaping clinical practice by examining ctDNA-guided adjuvant therapy decision-making for patients with stage II colorectal cancer.
- Hornstein argues that current approved agents are insufficient to change disease trajectory, and the real clinical transformation will come from next-generation drugs now in phase 2 and 3 trials.
- A c-MET inhibitor showed a 23% overall response rate in heavily pretreated metastatic colorectal cancer, while a RAS inhibitor plus PRMT5 inhibitor combination demonstrated over 90% disease control in pancreatic cancer.2 months agoImmunotherapy in Gastric Cancer: Moving to Earlier Disease Stages and Optimizing Combination Approaches- Leading oncologist Dr. Yelena Janjigian emphasizes the need to advance immunotherapy to earlier disease stages in gastric, GEJ, and esophageal cancers, with promising data expected from the MATTERHORN study.
- Recent evidence from phase 3 trials TOPGEAR and ESOPEC demonstrates that radiation therapy does not improve survival outcomes in gastric/GEJ cancers, challenging conventional treatment approaches.
- FLOT chemotherapy regimen combined with durvalumab represents an optimal treatment strategy for the perioperative setting, addressing the systemic nature of gastric cancer rather than focusing on localized radiation therapy.last yearAdvancements in Gastroesophageal Cancer: FLOT Regimens, HER2 Inhibition, and Zolbetuximab• FLOT (docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil) is now the preferred regimen for localized adenocarcinoma, as radiation therapy has not shown improved outcomes.
• The FDA approval of zolbetuximab plus chemotherapy marks a significant advancement for Claudin 18.2 (CLDN18.2)-positive gastric/gastroesophageal junction (GEJ) tumors.
• Research indicates that HER2 inhibition alone is insufficient for HER2-positive GEJ adenocarcinomas due to intrinsic resistance, necessitating combination therapies.
• Nivolumab plus FOLFOX demonstrates improved overall survival in microsatellite instability-high (MSI-H) gastric/GEJ/esophageal adenocarcinomas compared to chemotherapy alone.last year