NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma.
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:
Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?
Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?
Participants will:
Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)
Receive dual immunotherapy (nivolumab and ipilimumab)
Undergo evaluation by a multidisciplinary team to determine if surgery is possible
If operable, undergo extended pleurectomy/decortication surgery
Be followed for one year to assess side effects, quality of life, and survival
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of written informed consent and adherence to study procedures
- •Pathologically confirmed PM (epithelioid), cT2-3 N0-1 M0 according to UICC TNM 9 and considered inoperable by the Multidisciplinary Tumor Board of UZA/UZG at the start of the trail. They only enter the second surgical stage when becoming operable after neoadjuvant therapy
- •Aged 18 years or older
- •World Health Organization (WHO) Performance Status 0-1
- •Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice
- •No pregnancy allowed: women of childbearing potential have to take adequate contraception to avoid pregnancy; men need to take adequate contraception (usage of a condom) to avoid pregnancy in female partners
排除标准
- •Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant treatment according to TNM 9 criteria (some T3, all T4, N2-3, M1)
- •Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)
- •Patients unfit for systemic chemotherapy, immunotherapy or intrathoracic surgery. Patients with an active autoimmune disease or who have had prior splenectomy, an active/acute infection requiring antibiotics, a chronic infection (e.g. HIV, hepatitis B or C) or have a serious cardiac disease are unfit for systemic therapy because their immune system is not properly functioning
- •Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab, nivolumab) used in this study
- •Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix including brain metastases
- •Prior treatment with chemotherapy, immunotherapy, surgery (except for diagnostic thoracoscopy) or thoracic RT (including prophylactic tract irradiation)
- •Patients with significantly altered mental status or with psychological, familial, sociological or geographical conditions potential hampering compliance with the study as decided by the investigator
研究组 & 干预措施
Treatment
systemic treatment and surgery
干预措施: Neoadjuvant chemo-immunotherapy (Drug)
Treatment
systemic treatment and surgery
干预措施: Extended pleurectomy/decortication in case of reaching operability (Procedure)
结局指标
主要结局
To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma.
时间窗: The primary end point will be measured on week 17 +/-2 weeks
The primary endpoint is the rate of success, which is defined as a composite endpoint of feasibility, efficacy and safety consisting of: Feasibility is defined at week 17 +/- 2 weeks after start of treatment and involves the successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy, being selected as operable thereafter, and having extended pleurectomy/decortication (P/D). AND Efficacy is defined as being alive and without signs of progressive disease at week 17 +/- 2 weeks after start of treatment AND Safety is defined as absence of grade 3-4 residual toxicity from systemic treatment and complete resolution of major complications (grade III - V) after surgery according to the Ottawa Thoracic Surgery Morbidity and Mortality Classification at week 17 +/- 2 weeks after start of treatment Patients who are still inoperable after successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy are considered failure for the primary endp
次要结局
- Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.(The End of Treatment will be at 17 weeks)
- Efficay of neoadjuvant double chemotherapy / double immunotherapy regimen in inoperable T2-3 PM patients.(operability will be evaluated after systemic treatment on week 7-9.)
- Quality of life during the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.(at week 17)
研究者
Jeroen Hendriks
PhD & MD
University Hospital, Antwerp