RecruitingPhase 2NCT06323239

SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma

Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

148 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radiation therapies — targeted high-dose radiation (SBRT) to specific tumors and low-dose radiation (LDRT) to other sites — together with an immunotherapy drug (anti-PD-1 antibody) and chemotherapy for people with nasopharyngeal cancer (a cancer in the back of the nose and throat) that has come back or spread. **You may be eligible if:** - You have been diagnosed with recurrent or metastatic nasopharyngeal cancer (WHO type II or III) - You have not yet received any treatment for the recurrent or metastatic disease - Your physical fitness score (ECOG) is 0 or 1 - At least one tumor can safely receive targeted high-dose radiation - Your blood counts, liver, and kidney function are within acceptable ranges - You are willing to use effective contraception during and 3 months after treatment **You may NOT be eligible if:** - You have already received radiation, chemotherapy, or immunotherapy for this recurrence - You have a contraindication to immunotherapy or radiation - Your blood counts or organ function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

SBRT for metastatic lesions

RADIATIONLow-dose Radiotherapy (LDRT)

LDRT for metastatic lesions

DRUGToripalimab

6 cycles for combined therapy. Toripalimab maintenance for 1 year.

DRUGGemcitabine

6 cycles for combined therapy.

DRUGCisplatin

6 cycles for combined therapy.

RADIATIONIMRT

IMRT for primary lesion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06323239


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