PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First Line Chemotherapy

Overview

To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of recurrent/metastatic nasopharyngeal carcinoma after failure of first-line chemotherapy.

Full Title of Study: “PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First Line Chemotherapy:A Single Center, Single Arm, Phase II Clinical Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

Detailed Description

To evaluate the efficacy and safety of cendilizumab combined with bevacizumab in the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) after first-line chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), median time to response (MTTR), duration of response (DOR), adverse effects and quality of life.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: PD-1 immune checkpoint inhibitor combined with bevacizumab

Clinical Trial Outcome Measures

Primary Measures

  • objective response rate (ORR)
    • Time Frame: 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 Measures

  • overall survival (OS)
    • Time Frame: 2 years
    • Patients in clinical trials were randomized to the time of death from any cause
  • progression-free survival (PFS)
    • Time Frame: 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.
  • median time to response (MTTR)
    • Time Frame: 2 years
    • From the random date up to the median time of the first assessment of CR or PR.
  • duration of response (DOR)
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

Patients diagnosed with metastatic or recurrent 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. Previous use of bevacizumab. Previous use of sorafenib, apatinib, sunitinib, amlotinib and other small molecule vascular targeting drugs. Previous treatment with PD-1 mmune checkpoint inhibitor. 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. -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • XIANG YANQUN
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: XIANG YANQUN, professor – Sun Yat-sen University
  • Overall Official(s)
    • Yanqun Xiang, Dr., Principal Investigator, Sun Yat-sen University
  • Overall Contact(s)
    • Yanqun Xiang, Dr., +86-18666096623, xiangyq@sysucc.org.cn

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.