Testing personalized therapy for advanced cancer patients with fluid buildup
Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
This study is testing if personalized cancer treatments based on patients' own tumor samples can help people with advanced cancers like lung and breast cancer feel better and improve their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06413212 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of patient-derived tumor-like cell clusters (PTC) drug sensitivity testing in predicting clinical outcomes for patients with advanced malignancies such as lung, breast, gastric, and colorectal cancers. It plans to enroll 55 patients who will undergo PTC drug screening using fresh malignant effusion samples. Based on the screening results, patients will receive two cycles of personalized therapy, allowing researchers to assess the correlation between drug sensitivity results and actual treatment outcomes. The study seeks to enhance the precision of cancer treatment by tailoring therapies to individual patient profiles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced, unresectable malignancies who have shown resistance or intolerance to standard therapies.
Not a fit: Patients with severe liver or renal dysfunction, cognitive disorders, or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective personalized therapies for patients with advanced cancers.
How similar studies have performed: While similar approaches have been explored, this specific use of PTC drug sensitivity testing in advanced malignancies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 to 75 years old, regardless of gender. 2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023. 3. Advanced and unresectable malignancy confirmed by biopsy diagnosis. 4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases. 5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG≤2. 6. Anticipated survival exceed six months. 7. At least one measurable lesions (according to RECIST 1.1) 8. Resistance or intolerance to standard therapy regimens. 9. Signed informed consent form voluntarily. Exclusion Criteria: 1. Pregnant or lactating women. 2. Have Participated other clinical trials in six months. 3. Severe liver dysfunction. 4. Severe renal dysfunction. 5. Patients with cognitive disorder, mental diseases and terrible compliance. 6. Allergic to known chemotherapeutic agents. 7. Other circumstance not suitable to participate in this trial determined by investigators.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Liu Huang — Tongji Hospital
- Study coordinator: Liu Huang
- Email: huangliu@tjh.tjmu.edu.cn
- Phone: 63639656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.