Clinical trial · Observational
DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors
An Open, Single Center Clinical Study Based on DarwinOncoTreatTM (DOTr) and DarwinOncoTargetTM (DOTa) Algorithm Guidance for Treating Solid Tumor Patients Who Are Exhausted or Unable to Tolerate Standard Treatment Regimens
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Individuation | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recommended treatment plan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment group based on DOTr/DOTA detection result
- description
- Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility
- interventionNames
- Other: Recommended treatment plan
Primary outcomes (1)
- measure
- Feasibility of selecting treatment plans based on DOTr/DOTA result
- timeFrame
- Through study completion, an expected average of 2year
- description
- The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- Through study completion, an expected average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDMundi 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. PMID 37061969