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

NCT ID: NCT04872582

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2024-10-31

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.

Conditions

Metastatic Nasopharyngeal Carcinoma; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 immune checkpoint inhibitor combined with bevacizumab

Group Type: EXPERIMENTAL

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab

Intervention Type: DRUG

combined

Interventions

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab

combined

Intervention Type: DRUG

Other Intervention Names

Sintilimab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XIANG YANQUN

OTHER

Sponsor Role: lead

Responsible Party

XIANG YANQUN

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yanqun Xiang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Yanqun Xiang

Guangzhou, Guangdong, China

Countries

China

References

Lu 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.

Reference Type: DERIVED

PMID: 37593221 (View on PubMed)

Other Identifiers

B2021-078-01

Identifier Type: -

Identifier Source: org_study_id