NCT05578287招募中2 期
Disitamab Vedotin Combined With Tislelizumab, Low-dose Capecitabine and Celecoxib as Salvage Therapy for HER2-positive Metastatic Colorectal Cancer: a Phase II Trial (DETECT)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年7月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
As an established therapeutic target, HER2 is widely used in a variety of tumors, including breast cancer and gastric cancer, among which a variety of drugs, including trastuzumab, lapatinib and T-DM1, have been approved for the treatment of breast cancer and gastric cancer with HER2 amplification or overexpression. In colorectal cancer, HER2 as a target has also been focused in recent years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A voluntarily signed and dated informed consent must be obtained from the subject in accordance with regulations and institutional guidelines before performing any protocol-related procedures other than routine care;
- •Aged 18-75;
- •Patients with pathologically or cytologically confirmed adenocarcinoma of the colon or rectum with evidence of locally advanced lesions or metastases that could not be resected;
- •ECOG performance status score is 0-1;
- •Detection of HER2-positive tumor tissue at any time before screening; HER2 positive was defined as the presence of HER2 3+ positive staining in more than 50% of tumor cells on IHC. Or patients with a HER2 score of 2+ should also be tested by FISH: HER2/CEP17 ratio ≥2.
- •Appropriate organ function based on the following laboratory test values obtained during the screening period:
- •Neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤ 1.5× upper normal limits, UNL), aspartate aminotransferase ≤ 2.5×UNL, alanine aminotransferase ≤ 2.5×UNL, serum creatinine ≤ 1.5×UNL;
- •Previous chemotherapy including oxaliplatin, irinotecan, and fluorouracil failed, including the following:
- •Subjects using oxaliplatin as adjuvant therapy should have treatment progression within 6 months of completion of adjuvant therapy; Patients who refused standard chemotherapy because of unacceptable toxicity to treatment will be admitted to the study;
- •Previous or no previous anti-HER2-targeted therapy, disease progression or intolerable toxicity during or within 3 months after treatment;
- •Measurable lesions, according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1;
排除标准
- •Complicated with intestinal obstruction, active bleeding or perforation and requiring emergency surgery;
- •Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic organ resection, etc. within the previous 4 weeks (the surgical incision should be completely healed before enrollment);
- •Had active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction in the 12 months prior to study enrollment;
- •Thrombotic or embolic events occurred within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis;
- •The New York Heart Association (NYHA) class II or higher congestive Heart failure;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
- •The presence of any active, known or suspected autoimmune disease. To allow enrollment of subjects in stable condition who do not require systemic immunosuppressive therapy, such as type I diabetes, hypothyroidism that requires only hormone replacement therapy, and skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
- •The presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia);
- •Common Terminology Criteria for Adverse events that have not resolved due to any previous treatment CTCAE) (version 5.0) grade 2 or higher toxicity (except peripheral neurotoxicity, anemia, alopecia, skin pigmentation);
- •Previous recipients of PD-1/PD-L1 inhibitors or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies;
- •A history of known or suspected allergies to any of the relevant drugs used in the study;
- •Pregnant or lactating women.
研究组 & 干预措施
Anti-HER2
Experimental
Disitamab Vedotin (2mg/kg, once every 2 weeks), Tislelizumab (2mg/kg, once every 2 weeks) combined with low-dose capecitabine 0.5g bid chemotherapy and the COX2 inhibitor celecoxib 200mg bid as salvage therapy
干预措施: Anti-HER2 ADC (Drug)
结局指标
主要结局
Safety
时间窗: 1 year
Safety was assessed by evaluation of AEs and serious AEs according to CTCAE 5.0
Feasibility
时间窗: 1 year
Feasibility was determined based on any treatment -related AEs leading to delays over 15 days or discontinous of treatment.
次要结局
- Objective response rate(1 year)
- disease control rate,DCR(1 year)
- Progression-free survival (PFS)(1 year)
- Overall Survival (OS)(2 year)
研究者
Yanhong Deng
Director of Medical Oncology, Clinical Professor
Sun Yat-sen University
研究点 (1)
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