NCT04872582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

May 2, 2021

Last Update Submit

February 21, 2023

Conditions

Metastatic Nasopharyngeal CarcinomaChemotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

    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 Outcomes (3)

  • overall survival (OS)

    2 years

  • progression-free survival (PFS)

    2 years

  • duration of response (DOR)

    2 years

Study Arms (1)

PD-1 immune checkpoint inhibitor combined with bevacizumab

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

Interventions

PD-1 Immune Checkpoint Inhibitor Combined With BevacizumabDRUG

combined

Also known as: Sintilimab
PD-1 immune checkpoint inhibitor combined with bevacizumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yanqun Xiang

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Lu N, Jiang YF, Xia WX, Huang Y, Xie CM, Xu C, Ye YF, Liu GY, Bei WX, Ke LR, Li WZ, Zhang C, Wang X, Liu Q, Chen X, Chen ZX, Xie C, Liang H, Xiang YQ. Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. EClinicalMedicine. 2023 Aug 4;62:102136. doi: 10.1016/j.eclinm.2023.102136. eCollection 2023 Aug.

    PMID: 37593221DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Bevacizumabsintilimab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Yanqun Xiang, Dr.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 4, 2021

Study Start

July 29, 2021

Primary Completion

January 4, 2023

Study Completion

October 1, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)