Clinical trial NCT05177666: a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors
Official title: Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Feasibility
Effectiveness
Safety
Targeted Molecular Therapy
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Happy Life Technology Co., Ltd.
First posted: 2022-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From November 2021 to November 2022, the patients with refractory tumors who underwet the standard treatment standard treatment, went to the Shenzhen Hospital of the University of Hong Kong and were willing to have genetic testing for individualized targeted therapy. It is planned to enroll 120 patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2021.11-2023.11
measure: Proportion of targeted therapy guided by tumor molecular characteristics
timeFrame: 2021.11-2023.11
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2021.11-2023.11
measure: Overall survival (OS)
timeFrame: 2021.11-2023.11
measure: Best overall response (BOR)
timeFrame: 2021.11-2023.11
measure: Adverse events
timeFrame: 2021.11-2023.11
measure: Quality of Life Score (QoL)
timeFrame: 2021.11-2023.11
measure: Proportion of patients with intervening genomic variants
timeFrame: 2021.11-2023.11
Other outcomes:
measure: Changes in ECOG score before and after treatment
timeFrame: 2021.11-2023.11
measure: Proportion of targeted therapy guided by second tumor molecular characteristics
timeFrame: 2021.11-2023.11
Locations:
Study officials:
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Yongmei Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Weitang Wu
role: PRINCIPAL_INVESTIGATOR
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