This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.
1. Screen and enroll 120 patients with refractory solid tumors, and sign informed consents; 2. Extract the clinical data, including gender, age, disease diagnosis, past treatment history and genetic test results, etc.; 3. Take biopsy samples and perform NGS testing on patients. After discussion by the Molecular Steering Committee (MTB), the recommendations for treatment guidance will be given based on treatment guidelines and clinical experience; 4. The patient and the clinician jointly select the treatment plan and follow-up until the patient's disease progresses. The follow-up time will be 1 year; 5. During the follow-up period, clinical treatment and routine examination information of patients will be collected; 6. If the patient fails to receive molecular targeted therapy or they cannot tolerate the adverse reaction of the drug after adequate treatment, the clinician will evaluate whether a second NGS resistance test is needed or the participant may withdraw from the study.
Study Type
OBSERVATIONAL
Enrollment
120
Based on next-generation sequencing (NGS) detection, after discussion by the Molecular Steering Committee (MTB), intervention guidance suggestions are given based on domestic and foreign guidelines and clinical experience, and finally the patient and clinician jointly choose the treatment plan.
Objective Response Rate (ORR)
ORR is judged based on RECIST 1.1 criteria for all treatment groups at each visit period.
Time frame: 2021.11-2023.11
Proportion of targeted therapy guided by tumor molecular characteristics
The proportion of all enrolled patients receiving targeted therapy guided by tumor molecular characteristics during the study period, would be calculated, which defined as having received one or more the treatments based on tumor molecular characteristics.
Time frame: 2021.11-2023.11
Progression-free survival (PFS)
PFS is defined as the time from the first administration to disease progression or death.
Time frame: 2021.11-2023.11
Overall survival (OS)
OS is defined as the time from the first administration to death from any cause.
Time frame: 2021.11-2023.11
Best overall response (BOR)
The effectiveness of a patient would be evaluated multiple times, and the best one is defined as the best overall response.
Time frame: 2021.11-2023.11
Adverse events
The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard.
Time frame: 2021.11-2023.11
Quality of Life Score (QoL)
The QoL is evaluated by the scale (0PROMIS-29 Profile v2.1) at each visit period for all the enrolled patients.
Time frame: 2021.11-2023.11
Proportion of patients with intervening genomic variants
The intervening genomic variants are defined by the conclusion after MTB discussion.
Time frame: 2021.11-2023.11
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