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

Phase 2

Active, not recruiting

• Conditions: Metastatic Nasopharyngeal Carcinoma; Chemotherapy Effect
• Interventions: Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab

• Registration Number: NCT04872582
• Lead Sponsor: XIANG YANQUN

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.

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-04
• Study Start: 2021-07-29
• Primary Completion: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 immune checkpoint inhibitor combined with bevacizumab	PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Yanqun Xiang; 🇨🇳 Guangzhou, Guangdong, China