Status:
UNKNOWN
MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors
Lead Sponsor:
Tianjin Medical University Second Hospital
Conditions:
Refractory Solid Tumors
Next Generation Sequencing
Eligibility:
All Genders
18+ years
Brief Summary
The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The target population co...
Detailed Description
The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The target population co...
Eligibility Criteria
Inclusion
- Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid cancer of any histological type, or an earlier diagnosis of cancer with a poor prognosis. Suffificient accessible tissue for molecular profifiling;
- Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
- ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4));
- Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments;
- Signed, written informed consent to participate.
Exclusion
- Suitable for standard therapy;
- Specific contraindications to exposure to the investigationalproducts;
- Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol;
- Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer;
- Pregnancy, lactation or inadequate contraception.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06030869
Start Date
December 1 2020
End Date
December 31 2023
Last Update
September 11 2023
Active Locations (1)
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1
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China, 300211