NCT07842172尚未招募3 期
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed metastatic, unresectable, well- or moderately-differentiated, nonfunctional gastrointestinal neuroendocrine tumor (GI-NETs). This includes pancreatic neuroendocrine neoplasms. Any grade (grade 1, grade 2, or grade 3) is permitted.
- •Measurable disease per RECIST 1.
- •Appropriate for ethanol-stabilized Lu-177 dotatate treatment, as determined by positive screening with SSTR PET/CT and/or currently having received up to 3 fractions of PRRT. (Patients will be randomized prior to the start of PRRT or during PRRT, depending on the timing of enrollment.)
- •Eligible for somatostatin analogue treatment per the treating physician.
- •At least 18 years of age.
- •ECOG performance status ≤ 2 or Karnofsky ≥ 60%
- •Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable.
- •The effects of ethanol-stabilized Lu-177 dotatate and SSAs on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following last administration of PRRT for males and 7 months after last administration of PRRT for females, or 4 months after last day of SSA, whichever is later.
- •Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
排除标准
- •Completed prior treatment with PRRT for non-GI-NET diagnosis (i.e. in need of salvage PRRT treatment).
- •Major surgery within 4 weeks from randomization to the trial.
- •Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- •Currently receiving any investigational agents.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to SSAs.
- •Evidence of hypersensitivity to ethanol containing compounds.
- •Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 15 days of study entry.
研究组 & 干预措施
Arm 1: Somatostatin Analogue (SSA)
Experimental
Patients will receive SSA as per standard of care, starting within 3 months after PRRT. SSA administration (route of administration, dosing, and adjustments) is not dictated by this protocol, and SSAs may be given indefinitely.
干预措施: Somatostatin Analogue(s) (Drug)
Arm 2: Observation
No Intervention
Patients will be treated according to current standard of care guidelines.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
PFS is defined as the time from date of study enrollment to disease progression or death from any cause, whichever occurs first. The alive patients without progression or the dropouts, are censored at the last follow-up.
次要结局
- Overall Response Rate (ORR)(Start of treatment until completion of follow up (total estimated time 48 months))
- Overall Survival (OS)(Start of treatment until death (total estimated time 48 months))
- Incidence of adverse events (AEs) as assessed by CTCAE v6.0(Start of treatment until completion of follow up (total estimated time 48 months))
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
A study to test the effect of Safuf-i-Dhayabitus on lowering blood sugar in people with Type 2 diabetesType 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,CTRI/2026/02/104932Central Council for Research in Unani Medicine (CCRUM)100
招募中
2 期
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant TumorsAdvanced Gynecological MalignanciesNCT07448922Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.280
招募中
2 期
Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell TransplantationGraft-Versus-Host DiseaseSteroid-Refractory Acute Graft-Versus-Host DiseaseAcute Graft-Versus-Host DiseaseAllogeneic Hematopoietic Stem Cell TransplantationNCT07572669Union Hospital, Tongji Medical College, Huazhong University of Science and Technology42
尚未招募
3 期
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast CancerResectable HER2-positive Breast CancerNCT07441460Shanghai JMT-Bio Inc.1,800
招募中
4 期
RWS of Tunlametinib in NRAS-Mutant Advanced MelanomaMelanoma AdvancedNCT07445022Fudan University110