Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System

Официальное название

Real-world Study to Investigate Optimal Standard Treatment Selection for Solid Tumor Patients by Guided by Biologically-informed Multi-agent System

Обзор

This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients, including including demographics, clinical information, and multi-omics data. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

Подробное описание

This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. The study will prospectively collect patient data of multiple dimensions, including demographics, clinical information (pathological classification, tumor staging, imaging findings, previous treatment regimens and their effectiveness, performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, transcriptome sequencing, etc.). A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

Вмешательства

• Препарат Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.
  Quasar is a biologically-informed multi-agent system developed based on multi-omics and multi-modal data. By integrating multidimensional information such as patients' demographic, clinical, and omics data (including DNA genotyping, whole-exome sequencing, transcriptome sequencing, etc.), it prioritizes standard treatment plans and recommends the optimal personalized treatment plan. Including targeted drugs, chemotherapy, immunotherapy approved by China CDE.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]

Вторичные конечные точки (6)

• Overall response rate (ORR) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]
• Duration of response (DoR) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]
• Time to treatment failure (TTF) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]
• Time to progression (TTP) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]
• Best of response (BoR) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]
• Treatment-emergent adverse events (TEAE) [Срок оценки: Every 6 weeks, up to 2 years since enrollment]

Критерии участия

Критерии включения

• Voluntarily participate in the clinical study, fully understand and be informed about the study, sign the informed consent form, and be willing and able to comply with and complete all trial procedures.
• Aged ≥18 years, no gender restrictions.
• Patients with advanced or metastatic malignant tumors confirmed by histology or cytology.
• Able to provide tumor tissue and peripheral blood samples for multi-omics testing, or able to provide qualified whole-exome sequencing and transcriptomics data.

Критерии исключения

• As assessed by the investigator, no standard treatment is available, or the patient is unsuitable for guideline-recommended anti-tumor therapies.
• Other conditions deemed unsuitable for participation in this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Langfang Branch) — Langfang

Идентификаторы

NCT: NCT06824792 · SINGULARITY-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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