a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

• Conditions: Effectiveness; Targeted Molecular Therapy; Safety; Feasibility

• Registration Number: NCT05177666
• Lead Sponsor: The University of Hong Kong-Shenzhen Hospital

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.

Study Timeline

• Study First Submitted: 2021-11-24
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study Start: 2021-12-30
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival (OS)	2021.11-2023.11	OS is defined as the time from the first administration to death from any cause.
Progression-free survival (PFS)	2021.11-2023.11	PFS is defined as the time from the first administration to disease progression or death.
Adverse events	2021.11-2023.11	The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard.
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.
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.
Proportion of patients with intervening genomic variants	2021.11-2023.11	The intervening genomic variants are defined by the conclusion after MTB discussion.