NCT05229315

Brief Summary

To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).

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
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

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

January 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 12, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

January 25, 2022

Last Update Submit

April 11, 2023

Conditions

Nasopharyngeal CarcinomaT2-3N0 or T1-2N1EBV-DNA≤4000 Copy/ml

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    The severity of adverse events will be determined by the investigator based on CTCAE v 5.0

    Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment

Secondary Outcomes (4)

  • overall survival (OS)

    2 years

  • progression-free survival (PFS)

    2 years

  • Distant metastasis-free survival(DMFS)

    2 years

  • Response rate (based on RECIST ver1.1)

    Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment

Study Arms (1)

PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy

EXPERIMENTAL

Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total

Drug: ToripalimabProcedure: Intensity modulated radiotherapy

Interventions

ToripalimabDRUG

PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total

Also known as: Programmed cell death protein 1(PD-1)；Immune checkpoint inhibitors（ICIs)
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
Intensity modulated radiotherapyPROCEDURE

Intensity modulated radiotherapy

PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed patients who have not received radiotherapy or chemotherapy
  • Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).
  • T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml
  • Male or non-pregnant female
  • Age between 18 and 65
  • Eastern Cooperative Oncology Group（ECOG）score of 0-1.
  • Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
  • Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<2.0 times the upper limit of normal (ULN); total bilirubin \<2.0×ULN.
  • Renal function: creatinine clearance rate ≥60ml/min or serum creatinine \<1.5×ULN.
  • The patient has signed the informed consent

You may not qualify if:

  • The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).
  • Patients with recurrence and distant metastasis.
  • Patients who have undergone radiotherapy or chemotherapy.
  • Active hepatitis B (HBV-DNA≥500).
  • Patients with autoimmune diseases.
  • Patients with HIV infection.
  • At the same time suffering from other uncontrolled serious diseases.
  • Persons with abnormal functions of the heart, brain, lungs and other important organs.
  • Age\> 65 years.
  • pregnancy or breast feeding.
  • Persons with personality or mental illness, without or with limited capacity for civil conduct

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yanqun Xiang

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimabRadiotherapy, Intensity-Modulated

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)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Yanqun Xiang, Dr

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqun Xiang, Dr

CONTACT

+86-18666096623xiangyq@sysucc.org.cn

Weixiong Xia, Dr

CONTACT

+86-18520415699xiawx@sysucc.org.cn

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

January 25, 2022

First Posted

February 8, 2022

Study Start

March 12, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)