Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE..
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Study to Investigate Optimal Standard Treatment Selection for Solid Tumor Patients by Guided by Biologically-informed Multi-agent System
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Every 6 weeks, up to 2 years since enrollment]
Secondary outcome measures (6)
- Overall response rate (ORR) [Time frame: Every 6 weeks, up to 2 years since enrollment]
- Duration of response (DoR) [Time frame: Every 6 weeks, up to 2 years since enrollment]
- Time to treatment failure (TTF) [Time frame: Every 6 weeks, up to 2 years since enrollment]
- Time to progression (TTP) [Time frame: Every 6 weeks, up to 2 years since enrollment]
- Best of response (BoR) [Time frame: Every 6 weeks, up to 2 years since enrollment]
- Treatment-emergent adverse events (TEAE) [Time frame: Every 6 weeks, up to 2 years since enrollment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Langfang Branch) — Langfang
Identifiers
NCT: NCT06824792 · SINGULARITY-001