Precision medicine for patients with advanced solid tumors who have exhausted standard treatments

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

This study aims to evaluate the feasibility of personalized treatment plans based on genomic variations in patients with advanced refractory solid tumors. It involves comprehensive genome sequencing to identify potential targeted therapies for patients who have not responded to conventional treatments. The study will monitor treatment efficacy, safety, and tumor resistance mutations over time, utilizing a Bayesian adaptive trial design to optimize treatment combinations and dosages. Participants will be followed for clinical outcomes, including progression-free survival and changes in tumor characteristics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Recurrent or metastatic malignant solid tumors diagnosed by histology or cytology;
2. ECOG score 0-4 (3-4 points only for patients with tumor burden);
3. Those who fail or cannot tolerate standard treatment, or those who refuse standard treatment;
4. At least one measurable lesion that meets the RECIST 1.1 standard;
5. Expected survival period ≥ 3 months;
6. Age ≥ 18 years old;
7. Tumor tissue blocks with sufficient formalin fixed paraffin embedding (FFPE), or chest or ascites with cancer cells detected during treatment (not less than 200ml), or excised metastatic lymph nodes, or peripheral blood (approximately 5m1) can be used for genetic testing;
8. Understand and voluntarily participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Patients who have actively undergone or are currently participating in clinical trials for treatment;
2. Serious or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental diseases/social conditions that limit the compliance with the research requirements) that the researchers think will confuse the research treatment response analysis;
3. Pregnant or lactating patients, or any patients with fertility, have not taken appropriate pregnancy prevention measures.

Where it's running

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

Study contacts

• Principal investigator: Haitao Wang, Ph.D — Tianjin Medical University Second Hospital
• Study coordinator: Haitao Wang, Ph.D
• Email: peterrock2000@126.com
• Phone: +86-022-88326385

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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.