NL-OMON52108招募中2 期
Anti-PD-1, Capecitabine, and Oxaliplatin for the first-line treatment of dMMR esophagogastric cancer (AuspiCiOus-dMMR): a proof-of-principle study - AuspiCiOus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
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 64（—）
入选标准
- •- Male or female adult patients (> 18 years)
- •- Primaire tumor or metastasis accessible for repeat fresh histological biopsies
- •- dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6
- •- Patients with histologically confirmed diagnosis of metastatic or
- •irresectable HER2 negative adenocarcinoma of the stomach or oesophagus;
- •patients with HER2 positive disease are eligble when treatment with trastuzumab
- •is contraindicated. If histology cannot be obtained, cytology is acceptable to
- •prove metastatic disease
- •- Patients with metastatic or irresectable adenocarcinoma of the stomach or
- •oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable
- •or metastatic disease. Palliative radiotherapy on the primary tumor or a
- •metastatic lesion is allowed if other untreated lesions eligble for evaluation
- •are present
- •- Measurable disease as assessed by RECIST 1.1
- •- ECOG (WHO) performace status 0-2
- •- Patient has adequate hepatic, renal and hematological function
排除标准
- •- Severe renal impairment (CLcr <= 30 ml/min)
- •- Any prior anti-cancer chemotherapy, biologic or investigational therapy for
- •metastatic or irresectable stomach or oesophageal cancer
- •- Disease progression within six months after completion of (neo)adjuvant
- •chemotherapy containing a fluoropyrimidine and/or platinum compound. (Disease
- •progression within 6 months after completion of neoadjuvant chemoradiation
- •carboplatin AUC 2 and paclitaxel 50 mg/m2 is allowed.)
- •- Patient has known brain metastases, unless previously treated and
- •well-controlled for at least 3 months (defined as clinically stable, no edema,
- •no steroids and stable in 2 scans at least 4 weeks apart).
- •- Past or current malignancy other than entry diagnosis interfering with
- •prognosis of metastatic esophagogastric cancer.
- •- Complete dihydropyrimidine dehydrogenase deficiency.
- •- Use of other investigational drugs within 30 days of enrollment.
- •- Patient is enrolled in any other clinical protocol or investigational trial
- •that will interfere with the primary endpoint of the current study.
- •- Treatment within 4 weeks with DPD inhibitors, including sorivudine or its
- •chemically related analogues such as brivudine.
- •- Pre-existing motor or sensory neurotoxicity greater than CTCAE grade 1.
研究者
相似试验
招募中
1 期
Anti-PD-1, Capecitabine, and Oxaliplatin for the first-line treatment of dMMR esophagogastric cancer(AuspiCiOus-dMMR): a proof-of-principle studyMetastatic upper gastrointestinal cancer, cancer of esophagus and stomachCTIS2023-509380-24-00Amsterdam UMC25
进行中（未招募）
1 期
Study on the treatment of patients with gastroesophageal cancer with chemotherapy and immunotherapy based on a non-functioning DNA mismatch repair mechanism in the tumour cellsGastroesophageal cancerEUCTR2021-001181-38-NLAcademic Medical Center25
招募中
2 期
eoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in non-metastatic, resectable gastric and GE-junction cancer. ;The PANDA trialgastric cancerstomach cancer10017990NL-OMON50269ederlands Kanker Instituut20
招募中
2 期
Pre-operative capecitabine, oxaliplatin, docetaxel and atezolizumab in gastric cancer (PANDA)2024-519075-26-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting21
招募中
2 期
Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)Gastric AdenocarcinomaEsophageal AdenocarcinomaNCT05177133Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)25