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Trial Title:
DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors
NCT ID:
NCT06009835
Condition:
Solid Tumor
Individuation
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Recommended treatment plan
Description:
Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert
opinions, and drug accessibility
Arm group label:
Treatment group based on DOTr/DOTA detection result
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 the feasibility, efficacy, and safety of selecting treatment
regimens based on DOTr/DOTa results for solid tumor patients who have exhausted or cannot
tolerate standard treatment regimens.
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 invert the transcriptional activity of hyperconnected MR modules,
produced highly significant 30-day disease control rates (68% and 91%, respectively).
Criteria for eligibility:
Study pop:
Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 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;
2. Patients aged ≥ 18 years old;
3. Solid tumor patients who are depleted of standard treatment or unable to tolerate
standard treatment regimens;
4. According to the RECIST solid tumor efficacy evaluation criteria, there should be at
least one measurable lesion;
5. ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
6. The expected survival period is not less than 12 weeks;
7. 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;
8. The subjects voluntarily joined this study, signed an informed consent form, had
good compliance, and cooperated with follow-up;
9. 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 Criteria:
1. Severe heart disease or discomfort that cannot be treated;
2. Those who suffer from mental illness or abuse of psychotropic substances and are
unable to cooperate;
3. Pregnant or lactating female patients;
4. Participating in other clinical trials at the same time;
5. Researchers believe that individuals are not suitable for enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical Unversity Second Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Wang, Ph.D
Phone:
+86-022-88326385
Email:
peterrock2000@126.com
Contact backup:
Last name:
Lili Wang, MM
Phone:
+86-022-88326610
Email:
wangliliaigang@163.com
Investigator:
Last name:
Haitao Wang
Email:
Principal Investigator
Investigator:
Last name:
Lili Wang
Email:
Sub-Investigator
Investigator:
Last name:
Jinhuan Wang
Email:
Sub-Investigator
Investigator:
Last name:
Dingkun Hou
Email:
Sub-Investigator
Start date:
August 7, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Tianjin Medical University Second Hospital
Agency class:
Other
Source:
Tianjin Medical University Second Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009835
