Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

Study Overview
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Brief Summary
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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
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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 point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.

Official Title
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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.

Conditions
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Metastatic Nasopharyngeal Carcinoma, Chemotherapy Effect

Intervention / Treatment
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* Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 immune checkpoint inhibitor combined with bevacizumab<br> | Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab<br>* combined<br>* Other names: Sintilimab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR) | 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). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | Patients in clinical trials were randomized to the time of death from any cause | 2 years | 
| progression-free survival (PFS) | 36/5000 The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause. | 2 years | 
| duration of response (DOR) | The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause. | 2 years |