Chemotherapy Effect, Metastatic Nasopharyngeal Carcinoma
Conditions
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 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.
Interventions
DRUGPD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
combined
Sponsors
XIANG YANQUN
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 2 years | Patients in clinical trials were randomized to the time of death from any cause |
| progression-free survival (PFS) | 2 years | 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. |
| duration of response (DOR) | 2 years | The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause. |
Countries
China
Outcome results
None listed