Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Plain-language summary

This study evaluates molecular matching therapies (such as Olaparib, Lenvatinib, Alpelisib, or PD-1/PD-L1 inhibitors) selected according to a tumor's genetic features in patients with advanced or metastatic solid tumors who have exhausted standard treatment. Adults aged 18 and over with histologically confirmed tumors who have failed or cannot tolerate standard therapy and have enough sample for genetic testing may take part. It is a Phase 2 study that is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Tianjin Medical University Second Hospital

Intervention

Olaparib tablet, Temozolomide capsule, Anlotinib, Trametinib tablet, Dabrafenib, Vebreltinib Enteric Capsules, Alpelisib Pill, Sacituzumab Govitecan-Hziy 180 MG, Lenvatinib Capsules, Pazopanib Pill, Palbociclib Pill, Chidamide, PD-1/PD-L1/PD-1&CTLA4 inhibitor, Target Gene

Start date

11/1/2024

Estimated completion

5/1/2027

Countries

China

Related genes

Locations

• Tianjin, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.