Status:
UNKNOWN
DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors
Lead Sponsor:
Tianjin Medical University Second Hospital
Conditions:
Solid Tumor
Individuation
Eligibility:
All Genders
18+ years
Brief Summary
This study is an open, single center clinical study targeting solid tumor patients who have exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is to investigate t...
Detailed Description
Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which identifies drugs that...
Eligibility Criteria
Inclusion
- The subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form;
- Patients aged ≥ 18 years old;
- Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
- According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
- ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
- The expected survival period is not less than 12 weeks;
- Women of childbearing age must have a Pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug;
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
- If the main organs function normally, they meet the following standards:
- The blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥ 50%.
Exclusion
- Severe heart disease or discomfort that cannot be treated;
- Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
- Pregnant or lactating female patients;
- Participating in other clinical trials at the same time;
- Researchers believe that individuals are not suitable for enrollment.
Key Trial Info
Start Date :
August 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06009835
Start Date
August 7 2022
End Date
September 1 2024
Last Update
August 24 2023
Active Locations (1)
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1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China