NCT04400539招募中2 期
Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the proportion of patients having the full multimodal treatment
研究概览
简要总结
Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma
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
- •ECOG Performance status (PS) 0-1 (WHO)
- •Unresectable Malignant Pleural Mesothelioma
- •suffering from unresectable MPM (n=20), relapsing after one or 2 lines of treatment with platinum-based doublet of chemotherapy (including pemetrexed) [Note: MPM patients having contra-indications for, or refusing chemotherapy may also be recruited], and candidate for palliative pleural procedure (i.e. thoracoscopy for pleurodesis by talc or by insertion of indwelled pleural catheter, IPC)
- •Documented progression after previous 1 or 2 lines of chemotherapy including Platinum/Pemetrexed chemotherapy*
- •Measurable disease according to modified RECIST 1.
- •Malignant pleural lesion assessed to be accessible by local PDT treatment during thoracoscopy, as validated by expert MTB ("MESOCLIN", Lille, France)
- •Histological diagnosis confirmed by national expert pathology panel ("MESOPATH" - Institut Léon Bérard, Lyon, France)
- •Weight loss <10%
- •available tumor tissue (archival or fresh)
- •obtention of an informed written consent before any specific procedure of the study
- •Decision to treat the patient within this clinical trial taken during MPM dedicated multidisciplinary board (RCP MESOCLIN in France )
- •Patient affiliated to and covered by social security for standard care
- •Women of child-bearing potential must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 5 months after the final dose of investigational product
- •Women of child-bearing potential must have a negative pregnancy test within 24h before administration of investigational product
- •First line patients may also be recruited if they declined or if they have contra-indications for chemotherapy.
排除标准
- •lack of informed written consent; or refusal to sign or to participate
- •Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 5 months after the last dose of nivolumab
- •Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 7 months after the last dose of nivolumab
- •a previous treatment by anti-PD-1 or anti-PD-L1 antibodies for their cancer or any other cancer in the last 5 years
- •hypersensitivity to Nivolumab (anti-PD-1 antibodies)
- •contra-indications for 5-ALA or PDT
- •contra-indications for thoracoscopy (VATS)
- •any other comorbidity precluding the feasibility of the therapeutic protocol: uncontrolled cardiac failure, pulmonary hypertension, liver or kidney severe dysfunction (creatinin clearance <60 ml/min), uncontrolled infection, or other disease according to the investigator
- •other cancer treated within 5 years before inclusion except baso-cellular skin carcinoma or cervical / bladder in situ carcinoma
- •inability to receive study information and to give informed consent
- •patient unable to have a clinical follow-up due to psychological, familial, social or geographical reasons
- •legal incapacity (people in jail), or under supervision (i.e. guardianship or curatorship)
- •treatment with experimental drug within 30 days before the start of the study
研究组 & 干预措施
Malignant Pleural Mesothelioma patients
Experimental
干预措施: intrapleural photodynamic therapy with videothoracoscopy (Device)
Malignant Pleural Mesothelioma patients
Experimental
干预措施: Nivolumab Injection (Drug)
结局指标
主要结局
the proportion of patients having the full multimodal treatment
时间窗: through study completion, an average of 24 months
the proportion of patients having the full multimodal treatment (target: 70% minimum of total patients,14 out of 20 patients) without inacceptable and unexpected toxicity (grade≥3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.
次要结局
- Kaplan Meier curve for progression free survival (mPFS)(through study completion, an average of 24 months)
- objective response rate (ORR) according to modified RECIST 1.1 criteria for mesothelioma for pleural lesions; RECIST 1.1 for all other targets(through study completion, an average of 24 months)
- Kaplan Meier curve for overall survival (mOS)(through study completion, an average of 24 months)
- quality of life (QoL) of patients by dedicated EORTC QLQ C30 (or LCSS-30) questionnaire(At baseline and)
- evaluation of chest pain using visual scale.(through study completion, an average of 24 months)
研究者
研究点 (1)
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