Effectiveness, Feasibility, Safety, Targeted Molecular Therapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTargeted therapy
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.
Sponsors
Tianjin Happy Life Technology Co., Ltd.
The University of Hong Kong-Shenzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Recurrent or metastatic malignant solid tumor confirmed by histology or cytology * Disease progression or intolerance after receiving standard treatment * With evaluable lesions (RECIST 1.1 standard) * Tumor tissue pieces with sufficient formalin-fixed paraffin-embedded (FFPE) can be used for genetic testing * ECOG PS score 0-4 (3-4 points only for patients with tumor burden) * Sign the informed consent form
Exclusion criteria
* The subject is participating in any other clinical research; * Researchers believe that serious or uncontrolled medical diseases (ie uncontrolled diabetes, chronic kidney disease, chronic lung disease, or uncontrolled active infections, mental illnesses/social conditions that restrict compliance with research requirements) that will confuse the analysis of research treatment response ； * Patients during pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 2021.11-2023.11 | ORR is judged based on RECIST 1.1 criteria for all treatment groups at each visit period. |
| Proportion of targeted therapy guided by tumor molecular characteristics | 2021.11-2023.11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with intervening genomic variants | 2021.11-2023.11 | The intervening genomic variants are defined by the conclusion after MTB discussion. |
| Adverse events | 2021.11-2023.11 | The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard. |
| Quality of Life Score (QoL) | 2021.11-2023.11 | The QoL is evaluated by the scale (0PROMIS-29 Profile v2.1) at each visit period for all the enrolled patients. |
| Progression-free survival (PFS) | 2021.11-2023.11 | PFS is defined as the time from the first administration to disease progression or death. |
| Overall survival (OS) | 2021.11-2023.11 | OS is defined as the time from the first administration to death from any cause. |
| Best overall response (BOR) | 2021.11-2023.11 | The effectiveness of a patient would be evaluated multiple times, and the best one is defined as the best overall response. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of targeted therapy guided by second tumor molecular characteristics | 2021.11-2023.11 | After targeted therapy drug resistance, then the proportion of targeted therapy guided by the second tumor molecular characteristics would be calculated during study period. |
| Changes in ECOG score before and after treatment | 2021.11-2023.11 | We compare the ECOG scores of each visit with the baseline, including the number and proportion, and the difference. |
Contacts
Primary ContactZhiyuan Xu, MD
Outcome results
None listed