RecruitingPhase 3NCT06235203

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

154 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment sequencing strategies — giving chemotherapy/immunotherapy before surgery (neoadjuvant) versus after surgery (adjuvant) — for patients with locally advanced recurrent nasopharyngeal carcinoma (NPC), a cancer at the back of the nose. **You may be eligible if...** - You have been diagnosed with recurrent nasopharyngeal carcinoma that has come back - Your cancer is surgically removable and has not spread to distant organs - You are 18 to 75 years old and in good enough health for surgery, chemotherapy, and immunotherapy - It has been at least 6 months since your previous radiation treatment finished, and you only had one prior course of radiation **You may NOT be eligible if...** - You have another cancer (diagnosed within the past 5 years) - You have a serious autoimmune disease or are taking high-dose steroids - You received radioactive particle implants previously - You have a live vaccine within 4 weeks of starting treatment 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

PROCEDUREendoscopic surgery

The tumor was resected by endoscopic nasopharyngectomy.

DRUGNeoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy

Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.

DRUGAdjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy

Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.

DRUGAdjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy

Ten courses of Toripalimab Injection and four to six courses of chemotherapy,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

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NCT06235203


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