Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05147844

Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

Led by Xinqiao Hospital of Chongqing · Updated on 2025-07-14

40

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

X

Xinqiao Hospital of Chongqing

Lead Sponsor

S

Southwest Hospital, China

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma

CONDITIONS

Official Title

Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent and able to follow study procedures
  • Age between 18 and 75 years
  • Histologically or cytologically confirmed nasopharyngeal carcinoma
  • Metastatic nasopharyngeal carcinoma confirmed by pathology or imaging (Clinical stage IVB per 8th AJCC edition)
  • Oligometastatic disease confirmed by imaging (up to 5 metastatic lesions in 2 or fewer organs)
  • No prior treatment for metastatic nasopharyngeal carcinoma
  • Unsuitable or unwilling to receive chemotherapy as judged by investigator
  • ECOG Performance Status score of 0 or 1
  • Estimated life expectancy of at least 6 months
  • At least one measurable lesion per RECIST v1.1
  • Adequate organ function verified by recent laboratory tests
Not Eligible

You will not qualify if you...

  • Allergy to any component of toripalimab
  • Active autoimmune disease or history of autoimmune disease likely to relapse (except controlled conditions)
  • Any active malignancy within 2 years except specified cured cancers
  • Recent use of corticosteroids (≥10 mg prednisone daily) or systemic immunosuppressants
  • Uncontrolled diabetes or significant electrolyte abnormalities
  • History of interstitial lung disease, non-infectious pneumonia, or severe pulmonary conditions
  • Severe infections requiring systemic treatment within 14 days
  • HIV infection
  • Contraindications to immunotherapy or radiotherapy
  • Untreated chronic hepatitis B or active hepatitis C
  • Recent major surgery requiring general anesthesia within 28 days
  • Previous allogeneic stem cell or organ transplantation
  • Significant cardiovascular risks within 6 months prior to enrollment
  • Grade 2 peripheral nerve disease per NCI-CTCAE V5.0
  • Medical conditions affecting drug administration, safety assessment, or compliance
  • Participation in another interventional clinical trial concurrently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, China, 400000

Actively Recruiting

2

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China, 40037

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Toripalimab Combined With Radiotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma | DecenTrialz