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

A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion

This study is testing personalized treatment plans based on genetic differences to see if they can help people with advanced solid tumors who haven't had success with standard treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06739395 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent or metastatic solid tumors that have failed standard treatments.

Not a fit: Patients currently participating in other clinical trials or those with uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced solid tumors who have limited options.

How similar studies have performed: Other studies utilizing genomic matching for targeted therapies have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• 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

Conditions: Solid Tumor, Precision Medicine