Clinical trial · Interventional
Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study
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.
NCT04872582CI-TRIAL-00064201unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Metastatic Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 immune checkpoint inhibitor combined with bevacizumab
- interventionNames
- Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- 2 years
- description
- The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).
Secondary outcomes (3)
- measure
- overall survival (OS)
- timeFrame
- 2 years
- description
- Patients in clinical trials were randomized to the time of death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLu N, Jiang YF, Xia WX, Huang Y, Xie CM, Xu C, Ye YF, Liu GY, Bei WX, Ke LR, Li WZ, Zhang C, Wang X, Liu Q, Chen X, Chen ZX, Xie C, Liang H, Xiang YQ. Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. EClinicalMedicine. 2023 Aug 4;62:102136. doi: 10.1016/j.eclinm.2023.102136. eCollection 2023 Aug. PMID 37593221