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

Chemotherapy Effect Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872582
• Other study ID #: B2021-078-01
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Chemotherapy Effect
• Metastatic Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

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