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NCT Number: NCT06824792

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.

Drug

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.

Other names: KEYTRUDA et al.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the time from enrollment to documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the proportion of cases showing the best response of complete response (CR) or partial response (PR) (i.e., CR+PR) per RECIST 1.1 (based on CT, MRI or PET-CT), during the period from the start of the investigational drug to withdrawal from the trial.

  2. Duration of response (DoR)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the time from the first documented response, i.e. CR or PR, per RECIST 1.1, to disease progression or death from any cause, whichever occurs first.

  3. Time to treatment failure (TTF)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the time from the start of enrollment to the termination of treatment for any reason, including disease progression per RECIST 1.1, treatment toxicity, or death.

  4. Time to progression (TTP)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the time from enrollment to the occurrence of objective tumor progression per RECIST 1.1, excluding death.

  5. Best of response (BoR)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as the best therapeutic effect recorded from the start of treatment until disease progression or recurrence, per RECIST 1.1.

  6. Treatment-emergent adverse events (TEAE)

    Time frame: Every 6 weeks, up to 2 years since enrollment

    Defined as adverse events that emerge or worsen in severity following the initiation of intervention, per CTCAE 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Ning LI, M.D.

CONTACT

[email protected]

+86 (010) 8778-8165

Yale JIANG, M.D.

CONTACT

[email protected]

+86 (010) 8778-8713

Sponsors and collaborators

Lead sponsor

NING LI

Other

Registry information

Official study title

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

Acronym: SINGULARITY

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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