Status:
UNKNOWN
Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study
Lead Sponsor:
XIANG YANQUN
Conditions:
Metastatic Nasopharyngeal Carcinoma
Chemotherapy Effect
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end poi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04872582
Start Date
July 29 2021
End Date
October 1 2024
Last Update
February 23 2023
Active Locations (1)
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1
Yanqun Xiang
Guangzhou, Guangdong, China, 510000