nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Nab-TPC regimen
Sponsors
Sun Yat-Sen University Cancer center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age is greater than 18 years old. 2) Physical status (ECOG) score 0~1 points. 3) Life expectancy is at least 12 weeks. 4) Patients with metastatic nasopharyngeal carcinoma or neck. 5) Chemotherapy with paclitaxel or gemcitabine regimen was not accepted within six months. 6) At least 4 weeks apart from the previous chemotherapy. 7) The subject has at least one (RECIST standard) measurable lesion (the tumor lesion located in the original radiotherapy area is not selected as a measurable lesion). 8) Perform the following laboratory tests to assess bone marrow, liver, and kidney function within the first 7 days of screening: i. --hemoglobin > 8.0 g/dl. Ii. --Absolute neutrophil count (ANC) >1,500/mm3. Iii. --Platelet count > 100,000/µl. Iv. -- Total bilirubin <= 1.5 times the upper limit of normal (ULN). v. - alanine aminotransferase and aspartate aminotransferase < 2.5ULN (upper limit of normal), (a patient with liver metastasis, alanine aminotransferase and aspartate aminotransferase < 5ULN), alkaline phosphatase < 4ULN, Vi. -- Prothrombin time ( PT ) international normalized ratio / prothrombin time ( PTT ) < 1.5ULN, serum creatinine < 1.5ULN. 9) Subjects must sign and sign the date of informed consent prior to performing any of the procedures required.
Exclusion criteria
Exclusion criteria: 1) History of heart disease: congestive heart failure > NYHA cardiac function grade 2; active coronary heart disease (patients with myocardial infarction 6 months before the study can enter the trial); arrhythmia requires antiarrhythmia treatment (allowing beta Receptor blockers and digoxin) or uncontrolled high blood pressure. 2) History of HIV infection. 3) Clinically serious active infection (> grade 2, NCI-CTC version 5.0). 4) Metastatic brain tumor or meningeal tumor symptoms (unless the patient received radical treatment for more than 6 months, the imaging results were negative within 4 weeks of the study, and the clinical manifestations of the tumor were stable when entering the study). 5) History of allogeneic organ transplantation, except for the allowed organ allografts specified in the protocol. 6) Previous or combined malignant tumors differed from the tumors evaluated in this study at the primary site or histology, except for the following cases: cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumor [Ta, Tis and T1], or any tumor that has been cured 3 years before the study. 7) Pregnant or lactating female patients. Women of childbearing age must undergo a pregnancy test to exclude pregnancy within the first 7 days of treatment. Male and female patients participating in the study must take adequate barrier contraception for contraception during the trial and two weeks after the end of the trial. 8) Patients who cannot swallow oral medication. 9) Those who received other study medications other than the study within 4 weeks of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7 months of progression-free survival ;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective response;Toxicity; | — |
Countries
China
Contacts
Public ContactYanqun Xiang
Sun Yat-Sen University Cancer center
Outcome results
None listed