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A multicenter-center, one-arm exploratory clinical study for Apatinib mesylate combined with albumin-bound taxol in the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma

A multicenter-center, one-arm exploratory clinical study for Apatinib mesylate combined with albumin-bound taxol in the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026622
Enrollment
Unknown
Registered
2019-10-16
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

nasopharyngeal carcinoma

Interventions

case series: Apatinib combined with albumin-bound paclitaxel

Sponsors

Department of Oncology, Guigang City People’s Hospital, The Eighth Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Recurrence and/or metastasis nasopharyngeal carcinoma that has been histologically confirmed as non-operative, non-radiotherapy; 2. Patients who fail to receive platinum-based therapy are required to have at least received first-line chemotherapy containing platinum-based regimen.The disease progression occurred during the last chemotherapy with platinum-containing regimen =2.0 x10^9/L, hemoglobin >=90 g/L; platelets >=100x 10^9/L); 9. Signed the Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. People who are known to be allergic to any of the studied drugs; 2. Pregnant or lactating women; 3. Have participated in other drug clinical trials within 4 weeks prior to screening; 4. Patients who have received previous treatment with VEGFR-targeted small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, sunitinib, rigofini, amlotinib, furquintini, etc. 5. the case that the patient's tumor is highly likely to affect important blood vessels and cause fatal massive hemorrhage during the treatment; 6. Have a history of severe bleeding, and any bleeding events with severe grading up to more than two degrees in CTCAE4.0 within 4 weeks prior to screening; 7. Patients with hypertension who cannot obtain good control through single hypotensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);Clinical significance (such as active) of cardiovascular disease - such as cerebrovascular accident (6 months before the randomization or less), myocardial infarction (6 months before the randomization or less), unstable angina, New York heart association (NYHA) classification of grade II or above of congestive heart failure, or severe arrhythmia drugs control or the test should not be used to treat potentially influence; 8. Patients with active ulcers, perforations and intestinal obstruction; 9. A variety of factors (such as inability to swallow, postgastrectomy, chronic diarrhea, and intestinal obstruction) that affect the oral and absorption of drugs; 10. Patients with abnormal coagulation function 11. 6 months prior to screening, Occurred artery or vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (line by chemotherapy venipuncture vein thrombosis by researchers have judgment recovered except) and pulmonary embolism, etc.; 12. Renal insufficiency: routine proteinuria > 2+ and 24-hour urinary protein quantification > 1.0 g; 13. Those who underwent major surgery within 28 days; 14. Symptomatic brain metastases (confirmed or suspected); 15. There are severe or uncontrolled infections; 16. Persons who have a history of psychotropic substance abuse and cannot be cured or have a history of mental disorders; 17. Have a history of immunodeficiency disorders, including HIV positive tests, other acquired, congenital immunodeficiency disorders, or a history of organ transplantation; 18. Patients with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severely impaired lung function; 19. There have been other malignant tumors in the past 5 years, except the cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 20. According to the judgment of the researchers, there is serious harm to the patient's safety or the accompanying diseases that affect the patient's completion of the study; 21. With severe heart, lung, liver, kidney and other important organ dysfunction.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;Living quality;

Countries

China

Contacts

Public ContactWei Yan

Department of Oncology, Guigang City People's Hospital, The Eighth Affiliated Hospital of Guangxi Medical University

wyan184@163.com+86 13321686622

Outcome results

None listed

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