DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

NCT06009835 | Unknown

• 1 other identifier: DOTr/DOTa for Solid Tumor
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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 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

Solid Tumor; Individuation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• ORR

  Through study completion, an expected average of 1 year

• PFS2/PFS1

  Through study completion, an expected average of 1 year

• AEs

  Through study completion, an expected average of 1 year

Study Arms (1)

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

Other: Recommended treatment plan

Interventions

Recommended treatment plan OTHER

Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility

Treatment group based on DOTr/DOTA detection result

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37061969 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue

Study Officials

• HaiTao Wang, Ph.D

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HaiTao Wang, Ph.D

CONTACT

+86-022-88326385; peterrock2000@126.com

Lili Wang, Ph.D

CONTACT

+86-022-88326610; wangliliaigang@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: August 7, 2022
• Primary Completion: August 7, 2024
• Study Completion: September 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)