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

February 21, 2023 updated by: XIANG YANQUN

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.

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Yanqun Xiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 immune checkpoint inhibitor combined with bevacizumab
combined
Other Names:
  • Sintilimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 2 years
Patients in clinical trials were randomized to the time of death from any cause
2 years
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Yanqun Xiang, Dr., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

January 4, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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