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

XIANG YANQUN

Status and phase: Active, not recruiting; Phase 2

Conditions: Chemotherapy Effect; Metastatic Nasopharyngeal Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04872582

B2021-078-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

PD-1 immune checkpoint inhibitor combined with bevacizumab

Experimental group

Treatment:

Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab