ACTRN12623000874617尚未招募2 期
Phase II single arm study to explore the efficacy of cetuximab (in combination with irinotecan based treatment) in advanced stage RAS/BRAF wild-type right-sided colorectal cancer with high AREG/EREG expression
Australasian Gastrointestinal Trials Group0 个研究点目标入组 29 人开始时间: 2023年8月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Patients aged greater than 18 years of age
- •2. ECOG performance status 0-1
- •3. Patients with advanced colorectal cancer
- •4. Primary tumour arising from right side of colon (proximal to the splenic flexure)
- •5. RAS/BRAF wild type
- •6. Tumours with high AREG/EREG expression (less than 50% tumour cell positivity for either ligand) as determined by central laboratory testing.
- •7. At least one measurable lesion as per RECIST 1.1 criteria
- •8. Receipt of fluoropyrimidine and oxaliplatin containing therapy (FOLFOX,CAPOX or FOLFOXIRI) +/- bevacizumab as part of the initial treatment of advanced disease, or progression within 6 months of completing oxaliplatin based adjuvant therapy for early stage disease
- •9. Fit for treatment with cetuximab and irinotecan based treatment
- •10. Life expectancy greater than 3 months
排除标准
- •1. Previous exposure to an EGFR inhibitor
- •2. Grade 2 or greater diarrhoea at time of enrolment
- •3. Any contraindication to combination treatment with cetuximab + irinotecan based treatment
- •4. History of another primary cancer within the last 3 years that was either not treated with curative intent or has persisted or relapsed.
- •5. Patients with multiple primary colorectal cancers
- •6. Inadequate paraffin tumour sample available for AREG/EREG expression confirmation.
- •7. Tumours with low AREG/EREG expression levels ( less than 50% tumour cell positivity for either ligand) as determined by central laboratory testing of archival tumour tissue.
- •8. Inadequate organ function:
- •a. Moderate/severe renal impairment (GFR less than 45 ml/min), as calculated by the Cockcroft-Gault equation
- •b. Absolute neutrophil count less than 1.0x109/L
- •c. Platelet count less than 75x109/L
- •d. Haemoglobin less than 80 g/L (transfusion permitted)
- •e. Aspartate aminotransferase or Alanine aminotransferase greater than 2.5x upper limit of normal, or greater than 5x upper limit of normal if liver metastases are present
- •9. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- •10. Participants of child bearing potential unwilling to comply with effective contraceptive use for the duration of the study, including period of screening and 90 days following administration of last dose anti-cancer therapy.
- •11. Use of any concurrent chemotherapy (excluding irinotecan +/- a fluoropyrimidine), investigational product, biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g. Hormone replacement) is acceptable. Palliative radiotherapy for symptom control is allowed for sites of metastatic disease, which are non-target lesions and not included in RECIST response assessment.
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