Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis

Official title

Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis

Overview

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.

Detailed description

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.

Interventions

• Other Building Organoid-on-chips models
  This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.

Primary outcome measures

• ORR(Objective Response Rate) [Time frame: 18 months]
• Clinical Consistency [Time frame: 18 months]

Secondary outcome measures (2)

• Changes in tumor markers levels [Time frame: 18 months]
• PFS(Progression-free survival) [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

• Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
• Age ≥ 18 years old;
• ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
• Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, total bilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
• Can obtain surgical or biopsy samples;
• Patients voluntarily join this study and sign an informed consent form.

Exclusion criteria

• Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
• Patients who are unable to obtain tissue samples;
• Subjects with active pulmonary tuberculosis (TB);
• Subjects who are preparing for or have previously undergone tissue/organ transplantation;
• Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 2 centers

• Tianjin Medical Unversity Second Hospital — Tianjin
• Tianjin Medical Unversity Second Hospital — Tianjin

Identifiers

NCT: NCT06536725 · Organoid-on-chips-PCa

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗