Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with unresectable or metastatic tumors will have tumor organoids made from fresh tissue or effusions and tested against clinically available drugs. If the organoids accurately reflect drug sensitivity and establishing them succeeds, patients will receive treatment guided by those results plus multidisciplinary clinical judgment. Tumor responses will be monitored with RECIST 1.1, along with safety and survival follow-up. The study includes nine tumor-specific cohorts and follows patients through imaging and routine safety monitoring. If organoid culture fails or results are delayed beyond 28 days, the participant may be withdrawn from observational follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older; any sex.
2. Unresectable or metastatic disease with measurable lesions according to RECIST version 1.1; any number of prior lines of therapy.
3. Ability to obtain sufficient fresh tumor tissue or malignant effusion for organoid establishment before treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Estimated life expectancy of at least 6 months.
6. Willingness to participate, ability to comply with follow-up, and signed informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Clinically significant active cardiac disease within the past 12 months, including congestive heart failure, symptomatic coronary artery disease, arrhythmia, or myocardial infarction.
3. Another malignancy within the past 5 years, except cured skin cancer.
4. Uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic, or other infection within 4 weeks before enrollment, or a major systemic infection requiring intravenous antibiotics or hospitalization; tumor fever is excluded from this criterion.
5. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Where it's running

• Tianjin Medical University Second Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Lili Wang, Ph.D — Tianjin Medical University Second Hospital
• Study coordinator: Haitao Wang, Ph.D
• Email: peterrock2000@126.com
• Phone: +86-022-88321190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.