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

Sponsor
XIANG YANQUN (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04872582
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
38.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jul 29, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PD-1 immune checkpoint inhibitor combined with bevacizumab

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. overall survival (OS) [2 years]

      Patients in clinical trials were randomized to the time of death from any cause

    2. 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.

    3. median time to response (MTTR) [2 years]

      From the random date up to the median time of the first assessment of CR or PR.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yanqun Xiang Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • XIANG YANQUN

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    XIANG YANQUN, professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04872582
    Other Study ID Numbers:
    • B2021-078-01
    First Posted:
    May 4, 2021
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Nasopharyngeal Carcinoma
    Recurrence
    Bevacizumab
    Immune Checkpoint Inhibitors

    Study Results

    No Results Posted as of Aug 10, 2022