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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group based on DOTr/DOTA detection result | Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommended treatment plan | Other | Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of selecting treatment plans based on DOTr/DOTA result | The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test | Through study completion, an expected average of 2year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens | Through study completion, an expected average of 1 year |
| PFS2/PFS1 | he progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment; The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death |
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Inclusion Criteria:
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:
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Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HaiTao Wang, Ph.D | Contact | +86-022-88326385 | peterrock2000@126.com | |
| Lili Wang, Ph.D | Contact | +86-022-88326610 | wangliliaigang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| HaiTao Wang, Ph.D | Tianjin Medical University Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical Unversity Second Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37061969 | Background | Mundi PS, Dela Cruz FS, Grunn A, Diolaiti D, Mauguen A, Rainey AR, Guillan K, Siddiquee A, You D, Realubit R, Karan C, Ortiz MV, Douglass EF, Accordino M, Mistretta S, Brogan F, Bruce JN, Caescu CI, Carvajal RD, Crew KD, Decastro G, Heaney M, Henick BS, Hershman DL, Hou JY, Iwamoto FM, Jurcic JG, Kiran RP, Kluger MD, Kreisl T, Lamanna N, Lassman AB, Lim EA, Manji GA, McKhann GM, McKiernan JM, Neugut AI, Olive KP, Rosenblat T, Schwartz GK, Shu CA, Sisti MB, Tergas A, Vattakalam RM, Welch M, Wenske S, Wright JD, Canoll P, Hibshoosh H, Kalinsky K, Aburi M, Sims PA, Alvarez MJ, Kung AL, Califano A. A Transcriptome-Based Precision Oncology Platform for Patient-Therapy Alignment in a Diverse Set of Treatment-Resistant Malignancies. Cancer Discov. 2023 Jun 2;13(6):1386-1407. doi: 10.1158/2159-8290.CD-22-1020. |
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Tumor tissue
| Through study completion, an expected average of 1 year |
| AEs | Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 | Through study completion, an expected average of 1 year |