2023-510444-21-00招募中3 期
A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 33
- 主要终点
- 1. Progression-free survival (PFS)
研究概览
简要总结
To demonstrate the efficacy of PRRT with 177Lu-edotreotide to prolong progression-free survival (PFS) in patients with inoperable, progressive, SSTR+ GEP-NET, compared to everolimus
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Long-term Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Male or female ≥18 years of age
- •Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
- •Measurable disease per RECIST 1.1
- •Somatostatin receptor positive (SSTR+) disease
- •Progressive disease based on RECIST 1.
- •criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
排除标准
- •Known hypersensitivity to edotreotide or everolimus
- •Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
- •Pregnant or breast-feeding women
- •Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.)
- •Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative.
- •Prior exposure to any peptide receptor radionuclide therapy (PRRT)
- •Prior therapy with mTor inhibitors
- •Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy.
- •Therapy with an investigational compound and/or medical device within 30 days prior to randomization
- •Indication for surgical lesion removal with curative potential
- •Planned alternative therapy (for the period of study participation)
- •Serious non-malignant disease
结局指标
主要结局
1. Progression-free survival (PFS)
1. Progression-free survival (PFS)
次要结局
- 1. Objective response rate (ORR), % patients achieving PR or CR as best outcome
- 2. Overall survival (OS)
- 3. Safety and tolerability-Measured TER, percentage depart from baseline value
- 4. Safety and tolerability-Calculated GFR, percentage depart from baseline value
- 5. Safety and tolerability-Renal volume (Vkidney), percentage depart from baseline value
- 8. Health-related quality of life (HRQL)- Duration of maximum HRQL improvement
- 6. Safety and tolerability-Frequency of occurrence and severity of abnormal findings in safety investigations (vital signs, 12-lead ECG, clinical laboratory, adverse events)
- 7. Health-related quality of life (HRQL)- Maximum HRQL improvement (EORTC QLQ-C30 and GI.NET21 questionnaires) total scores, relative to baseline
- 9. Health-related quality of life (HRQL)- Time to HRQL deterioration, defined as the time from randomisation to first HRQL deterioration
- 10. Dosimetry- Full dosimetry assessments of target organs and tumour lesions
- 11. Dosimetry- Cumulative absorbed dose (in Gy) from 177Lu-edotreotide to target tumour lesions, estimated from 177Lu-edotreotide dosimetry after first dose
- 12. Dosimetry- Sub-study A patients: cumulative absorbed dose to kidneys and to tumour lesions extrapolated from absorbed dose estimated at D1 compared with the cumulative absorbed dose measured at the different administration times (i.e. D1 to D4)
- 13. Dosimetry- Sub-study B patients: absorbed dose (in Gy) determined by 3D dosimetry compared to absorbed dose values obtained by planar (2D) and hybrid (2D/3D) dosimetry
- 14. Dosimetry- Sub-study C patients: bone marrow absorbed dose (in Gy) extrapolated from blood radioactivity
- 15. Pharmacokinetics (Sub-study C) Urine radioactivity in percentage of injected activity (%IA) at pre-defined intervals within 48 hours post-injection to assess excretion pattern
- 16. Pharmacokinetics (Sub-study C) Blood radioactivity in %IA at pre-defined time points within 7 days post-injection to assess clearance pattern
- 17. Pharmacokinetics (Sub-study C)_Radiochemical purity assessed through HPLC of urine samples collected within 48 hours post-injection
研究者
General Information
Scientific
ITM Solucin GmbH
研究点 (33)
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