NCT05177666

a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: The University of Hong Kong-Shenzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Feasibility
• Effectiveness
• Safety
• Targeted Molecular Therapy

Interventions

Type	Name	Description
DRUG	Targeted 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.

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-12-30
• Completion: 2024-03-30
• First posted: 2022-01-04
• Last updated: 2022-01-04