PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.

B2021-078-01

To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

2021-07-29

2023-01-04

2024-10-01

Active (not recruiting)

Early phase I

33

Inclusion Criteria: * Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment. * Previous failure of first-line platinum-containing chemotherapy (single drug or combination). * Previously diagnosed WHO classification type II or III by histological pathology. * At least one measurable lesion (according to RECIST1.1). * Age between 18 and 70. * Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months. * Enough blood test. * Participate voluntarily and sign the informed consent. Exclusion Criteria: * Previously diagnosed WHO classification type I by histological pathology. * Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies. * Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding. * A history of interstitial pneumonia or other autoimmune diseases. * Sever infection. * Sever heart disease. * HIV infection. * Allogeneic organ transplantation * Malignancy other than nasopharyngeal carcinoma. * Pregnancy or breast feeding. * Received other test drugs.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}

2023-02-23