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Clinical research of advanced nasopharyngeal carcinoma patients treated by Apatinib mesylate tables: a second line therapeutical research.

Clinical research of advanced nasopharyngeal carcinoma patients treated by Apatinib mesylate tables: a second line therapeutical research.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-17010864
Enrollment
Unknown
Registered
2017-03-14
Start date
2017-03-21
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma (NPC)

Interventions

Case series:Apatinib

Sponsors

The First affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient aged 18-75 years old; 2. Patients with metastatic nasopharyngeal carcinoma diagnosed by histology or cytology; 3. Previously received standard first-line chemotherapy with cisplatin, 5-FU, taxane or gemcitabine regimen and failed treatment; 4. At least one measurable focus: at least one can accurately measure the diameter of CT MRI (maximum diameter) = 10mm); in the original field of radiation of the tumor is not selected as measurable lesions; 5. Expected survival time=three months; 6. ECOG physical condition score: 0~1 points; 7. No other antineoplastic concomitant therapies (including steroids, immunomodulatory drugs; 8. The main organs function well, that is, the week before entering the group to meet the following requirements: 1) Blood routine examination: Hemoglobin > 80 g/L; Neutrophil count > 1.5 * 10^9/L; Platelet count >80×10^9/L; 2) Biochemical examination: Total bilirubin is = 1.5×ULN(upper limit of the normal value); Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase(AST) <2.5×ULN; Serum creatinine<1.5×ULN; 9. Participants volunteered to join this study, signed informed consent, compliance, with follow-upge.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignancies other than basal tumors over the past 5 years; 2. Patients with active upper gastrointestinal ulcer, significant vomiting, chronic diarrhea, intestinal obstruction, malabsorption, or other known effects on drug absorption, distribution, metabolism or clearance; 3. Patients with gastrointestinal bleeding within the last 3 months; 4. Abnormal blood coagulation, with bleeding (informed consent 14 days before the book must be satisfied: without the use of anticoagulants in case of INR in the normal range); use of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues in the treatment of patients; prothrombin time international normalized ratio (INR) = 1.5 of the premise, to prevent the use of small doses to allow Hua Falin (1 mg orally, once daily) or low-dose aspirin (daily dosage of not more than 100 mg); 5. Suffering from hypertension and the single antihypertensive drug treatment cannot get good control (> 140 mmHg systolic blood pressure, diastolic blood pressure > 90 mmHg); congestive heart failure (left ventricular ejection fraction of 45% or less), myocardial infarction, chronic kidney disease, thyroid function abnormalities within 6 months; 6. Brain metastasis, meningeal metastasis or various mental disorders; 7. Pregnant or lactating female patients, or during the trial is not willing to contraception; 8. History of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation; 9. According to the researcher's judgment, there are serious hazards to the patient's safety or affect the patient to complete the study of the accompanying disease; 10. Patients who participated in other clinical trials within 4 weeks; 11. Received VEGFR inhibitors, such as Sola Fini and sunitinib; 12. Researchers considered unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Measurable lesion;

Countries

China

Contacts

Public ContactHu Xiaohua

The First affiliated Hospital of Guangxi Medical University

gxykdhxh@sina.com+86 0771-5359339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026