Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System
- Sponsor
- NING LI
- Study ID
- NCT06824792
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE. — DRUGQuasar 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.
Study Details
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.
Key Dates
- Start date
- Mar 1, 2025
- Status verified
- Feb 2025
- Primary completion
- Feb 29, 2028
- Completion
- Feb 28, 2030
Study Design
- Enrollment
- 3,000 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: QuasarThis arm involves the prospective collection of individual patient data, including demographic information, clinical details (such as pathological classification, tumor staging, imaging findings, prior treatments and their efficacy, and performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, and transcriptome sequencing). An artificial intelligence model (namely, Quasar) integrates this multidimensional information to prioritize standard treatment options and identify the optimal personalized treatment plan for each patient. Based on the AI-recommended treatment list, the final treatment plan is jointly selected by the patient and the physician. If treatment adjustments are required due to tumor progression, intolerance, or other reasons, the AI model will generate a new optimal treatment plan based on updated patient characteristics. This iterative process continues until the patient withdraws from the study.
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: Every 6 weeks, up to 2 years since enrollment ]
Central Contacts
- Ning LI, M.D.+86 (010) 8778-8165
- Yale JIANG, M.D.+86 (010) 8778-8713
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