Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC

Sun Yat-sen University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma; Distant Metastases.Clinical; Circulating Tumor Cell; Effects of Chemotherapy

Treatments: Drug: cisplatin-based chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT04544969

B2019-128

Details and patient eligibility

About

The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Chemotherapy

Description:

Patients treated with palliative chemotherapy

Treatment:

Drug: cisplatin-based chemotherapy