RecruitingPhase 3NCT06228079

Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

176 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches for treating nasopharyngeal carcinoma (NPC — a type of head and neck cancer) that has come back after initial radiation treatment: surgery alone versus surgery followed by additional anti-cancer therapy. **You may be eligible if...** - You have confirmed recurrent nasopharyngeal carcinoma - Your recurrent cancer is early-stage (rT1, rT2, or limited rT3) - You have had only one prior course of radiation - It has been at least 6 months since completing radiation before the recurrence - You recently had endoscopic surgery with clear (negative) margins - You are between 18 and 75 years old with no distant spread **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had more than one course of radiation previously - Your overall health is too poor to tolerate additional treatment - You have uncontrolled illnesses or are participating in another trial 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

DRUGImmunotherapy,Toripalimab Injection

Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

DRUGChemotherapy,Gemcitabine based regimen

Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.


Locations(7)

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Fujian Medical University Union Hospital

Fuzhou, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Changhai Hospital

Shanghai, China

Shanghai Sixth People's Hospital

Shanghai, China

Shanghai Zhongshan Hospital

Shanghai, China

Shenzhen Second People's Hospital

Shenzhen, China

View Full Details on ClinicalTrials.gov

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NCT06228079


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