NCT05011227

Brief Summary

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
recruiting

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

August 7, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

August 7, 2021

Last Update Submit

March 4, 2024

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

endoscopic surgeryInductive chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    2 year Overall Survival rate

    From date of first treatment until the date of death from any cause, up to 4 years.

Secondary Outcomes (5)

  • Local recurrence free survival

    From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.

  • Progression free survival

    From date of first treatment until the date of disease progression or death from any cause, up to 4 years.

  • Rate of negative margin

    At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.

  • distant metastasis free survival

    From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.

  • pathologic complete remission

    At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.

Other Outcomes (4)

  • quality of life-（EORTC QLQ) - C30 version3.0

    From date of first treatment to the end of study, at each visit, up to 4 years.

  • quality of life-（EORTC QLQ) - H&N35

    From date of first treatment to the end of study, at each visit, up to 4 years.

  • adverse effect

    From date of first treatment to the end of study, up to 4 years.

  • +1 more other outcomes

Study Arms (1)

Camrelizumab and chemotherapy combined with endoscopic surgery

EXPERIMENTAL

Camrelizumab and chemotherapy combined with endoscopic surgery

Drug: CamrelizumabDrug: ChemotherapyProcedure: endoscopic surgery

Interventions

CamrelizumabDRUG

2 cycles Camrelizumab before endoscopic surgery and one year after

Camrelizumab and chemotherapy combined with endoscopic surgery
ChemotherapyDRUG

2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery

Camrelizumab and chemotherapy combined with endoscopic surgery
endoscopic surgeryPROCEDURE

standard endoscopic surgery for recurrent nasopharyngeal carcinoma

Camrelizumab and chemotherapy combined with endoscopic surgery

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed recurrent nasopharyngeal carcinoma
  • American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed
  • Age ≥18 years old
  • Informed consent signed
  • With or without lymph node metastasis, which can be surgically removed
  • No massive hemorrhage risk recently
  • No distant metastasis
  • ≥6 months from initial radiotherapy to recurrence
  • Radical radiation only once
  • Sufficient organ function
  • Eastern Cooperative Oncology Group score 0-2

You may not qualify if:

  • With a history of allergic to platinum drugs and similar compounds
  • Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD)
  • Have received radioactive seed implantation in the treatment area
  • Suffer from uncontrolled disease which could interfere with treatment
  • Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.)
  • The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on
  • The patients have autoimmune diseases
  • The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration
  • Severe allergic reaction to other monoclonal antibodies
  • Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment
  • Live vaccines have been inoculated within 4 weeks before the first administration or during the study period
  • The patient has any situation that may hinder study compliance or the safety during the study period
  • Existence of serious neurological or psychiatric diseases, such as dementia and seizures
  • Uncontrolled active infection
  • Pregnant or breastfeeding women
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Shanghai Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumabDrug TherapyEndoscopy

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)

TherapeuticsDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hongmeng Yu, MD,PHD

    Eye&ENT Hospital,Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaole Song, MD

CONTACT

15821388769jxfxsxl@163.com

Study Design

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

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 18, 2021

Study Start

August 10, 2021

Primary Completion

August 10, 2025

Study Completion

August 10, 2025

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

CN(7)