Nasopharyngeal carcinoma
Conditions
Interventions
Case series:Antinib hydrochloride capsule
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of informed consent; 2. Subjects with recurrent nasopharyngeal carcinoma who have been histologically or cytologically confirmed as stage IVB or who are not suitable for local treatment according to the TNM staging system of AJCC nasopharyngeal carcinoma, 8th edition 2017; 3. Previously received standard first-line regiments including cisplatin, 5-FU, purple shirt or gemcitabine, and failed in treatment; 4. Regardless of gender, aged 18-70 years; 5. ECOG score 0-1, predicted survival >= 3 months; 6. Imaging evidence during the screening period showed a measurable target lesion (maximum diameter >= 10mm) as assessed by RECIST1.1; Tumor lesions located in the original radiation field were not selected as measurable lesions; 7. No other antitumor concomitant therapy (including steroid drugs and immunoregulatory drugs); 8. Function of major organs is good, i.e. the following conditions are met one week before enrollment: (1) Blood routine examination: neutrophils absolute value (ANC) >= 1.5 x 10^9 / L; platelet count (PLT) >= 100 x 10^9 / L; hemoglobin (Hb) >= 90 g/L or higher; (2) Blood biochemistry: total bilirubin 1.5 x ULN or less; aspartate transaminase (AST) and alanine aminotransferase (ALT) or less 2.5 x ULN, if subjects had spread to the lier, you have 5 or less x ULN. creatinine clearance calculated value or 60 ml/min (according to the standard formula Gault Cockcroft, see attachment 1). (3) Routine urine urine protein < 2 + (baseline urine protein 2 +, or within 7 days of 24 hours urinary protein quantitative detection, when urine protein quantitative < 1 g may be selected); (4) Coagulation function INR and APTT acuities were 1.5 x ULN (5) cardiac function left ventricular ejection fraction (LVEF) of 50% or more.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors other than basic tumors occurring in the past 5 years; 2. Patients with abnormal coagulation function and bleeding tendency (14 days before signing the informed consent, INR must be within the normal range without the use of anticoagulant); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; Low-dose warfarin (1 mg oral, qD) or low-dose aspirin (not more than 100 mg daily) is permitted for prophylactic purposes as long as the international standard ratio of prothrombin time (INR) is 140mmHg, diastolic blood pressure > 90 mmHg); Congestive heart failure (left ventricular ejection fraction <= 45%), myocardial infarction within 6 months, chronic kidney disease, thyroid dysfunction, etc. 9.4 Patients who have participated in clinical trials of other drugs within weeks; 10. VEGFR inhibitors such as sorafenib and sunitinib; 11. The researcher thinks that is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZheng Haiping
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed