Detecting how well chemotherapy works in patients with metastatic nasopharyngeal carcinoma using blood tests.
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
This study is testing if blood tests can help doctors see how well chemotherapy is working for people with metastatic nasopharyngeal carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04544969 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 50 patients with metastatic nasopharyngeal carcinoma (mNPC) to evaluate their response to cisplatin-based chemotherapy by analyzing circulating tumor cells (CTCs) from their blood. The study will monitor changes in CTCs to predict treatment efficacy and assess patients' chemosensitivity. Participants must have measurable metastatic lesions and meet specific health criteria to ensure their safety during the study. The findings could provide valuable insights into personalized treatment approaches for mNPC patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with metastatic nasopharyngeal carcinoma who have undergone primary radiotherapy and are not suitable for local treatment.
Not a fit: Patients with other malignant tumors, severe complications, or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored chemotherapy treatments for patients with metastatic nasopharyngeal carcinoma.
How similar studies have performed: While similar studies have explored the use of circulating tumor cells in various cancers, this specific approach in metastatic nasopharyngeal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment * At least having one measurable metastatic lesion * All genders，range from 18～70 years old * ECOG score 0 \~ 1 * Expected survival time ≥ 3 months * White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L * Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min * Inform consent form Exclusion Criteria: * Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Drug or alcohol addition; * Do not have full capacity for civil acts; * Mental disorder; * Pregnancy or lactation; * Severe complication, eg, uncontrolled hypertension.
Where this trial is running
Guangzhou, Guangdong
- Cancer Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Chong Zhao, M.D — Sun Yat-sen University
- Study coordinator: Jingjing Miao, M.D
- Email: miaojingjing90@163.com
- Phone: 86-13631355201
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.