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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04872582
Other study ID # B2021-078-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 29, 2021
Est. completion date October 2024

Study information

Verified date February 2023
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date October 2024
Est. primary completion date January 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
combined

Locations

Country Name City State
China Yanqun Xiang Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
XIANG YANQUN

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 overall survival (OS) Patients in clinical trials were randomized to the time of death from any cause 2 years
Secondary 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
Secondary 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
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