临床试验/NCT06739395

NCT06739395招募中2 期

A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion

Tianjin Medical University Second Hospital1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2024年11月1日最近更新: 2024年12月18日

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: 300
试验地点: 1
主要终点: PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.

详细描述

Using comprehensive genome sequencing to analyze recurrent and metastatic solid tumors that have failed previous conventional treatments, and matching possible targeted therapy drugs to screen for potential effective treatment drugs until tumor disease progression, and then continuing to monitor tumor resistance mutation signals and provide matching therapy, can help improve the clinical outcomes of patients with advanced refractory tumors, and is also an important direction for personalized and precise treatment of tumors in the future. Therefore, the investigators designed this study to explore the feasibility, effectiveness, and safety of targeted therapy based on tumor molecular feature matching for advanced solid tumor patients who have failed previous treatments. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including clinical efficacy ,clinical safety and exploratory endpoints such as biomarkers for drug response, change in the tumor microenvironment. The core concepts of the clinical research interventional initiated include: target priority principle, combination therapy principle, individualized dose adjustment method for combination therapy, and Bayesian adaptive trial design. For some clinical studies, to meet the primary objective, at least 35% of participants had to achieve a PFS2(Progression-Free Survival 2)/PFS1(Progression-Free Survival 1) ≥ 1.3 in a sample population of 25 evaluable patients. Sample size was calculated using an exact single-stage design for phase II studies with a one-sided type I error of 5% and a power of 90% under the assumption that PFS2/PFS1≥ 1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would merit further investigation.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Investigator)

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

•Recurrent or metastatic malignant solid tumors diagnosed by histology or cytology;
•ECOG score 0-4 (3-4 points only for patients with tumor burden);
•Those who fail or cannot tolerate standard treatment, or those who refuse standard treatment;
•At least one measurable lesion that meets the RECIST 1.1 standard;
•Expected survival period ≥ 3 months;
•Age ≥ 18 years old;
•Tumor tissue blocks with sufficient formalin fixed paraffin embedding (FFPE), or chest or ascites with cancer cells detected during treatment (not less than 200ml), or excised metastatic lymph nodes, or peripheral blood (approximately 5m1) can be used for genetic testing;
•Understand and voluntarily participate in this study, and sign the informed consent form.

排除标准

•Patients who have actively undergone or are currently participating in clinical trials for treatment;
•Serious or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental diseases/social conditions that limit the compliance with the research requirements) that the researchers think will confuse the research treatment response analysis;
•Pregnant or lactating patients, or any patients with fertility, have not taken appropriate pregnancy prevention measures.

研究组 & 干预措施

Monotherapy

Other

In the OncoKB(Precision Oncology Knowledge Base) database, the gene alteration has a variant of clinical evidence in this tumor or other tumor types and is considered to be an interventional variant. Cohort-1may include different observation subgroups（dMMR/MSI-H,TMB-H,NTRK fusion,RET-fusion,BRAF(p.V600E),KRAS(p.G12C),HER2(IHC,3+)）. For example, substudy-1: monotherapy/combination therapy for patients with A1-relative. Substudy-x: monotherapy/combination therapy for patients with Ax-relative.

干预措施: Target Gene (Drug)

Combination therapy-cohort1

Experimental

The characteristics of enrolled patients are the presence of two or more interventional or potential actionable targets(only TP53 alteration,MAP2K1 alteration,PMA pathway alteration,11q13 amplification,MET alteration).

干预措施: Olaparib tablet (Drug)

Combination therapy-cohort1

Experimental

干预措施: Temozolomide capsule (Drug)

Combination therapy-cohort1

Experimental

干预措施: Anlotinib (Drug)

Combination therapy-cohort1

Experimental

干预措施: Trametinib tablet (Drug)

Combination therapy-cohort1

Experimental

干预措施: Dabrafenib (Drug)

Combination therapy-cohort1

Experimental

干预措施: Vebreltinib Enteric Capsules (Drug)

Combination therapy-cohort1

Experimental

干预措施: Alpelisib Pill (Drug)

Combination therapy-cohort1

Experimental

干预措施: Sacituzumab Govitecan-Hziy 180 MG (Drug)

Combination therapy-cohort1

Experimental

干预措施: Lenvatinib Capsules (Drug)

Combination therapy-cohort1

Experimental

干预措施: Pazopanib Pill (Drug)

Combination therapy-cohort1

Experimental

干预措施: Palbociclib Pill (Drug)

Combination therapy-cohort1

Experimental

干预措施: Chidamide (Drug)

Combination therapy-cohort1

Experimental

干预措施: PD-1/PD-L1/PD-1&CTLA4 inhibitor (Drug)

Combination therapy-cohort1

Experimental

干预措施: Target Gene (Drug)