RecruitingNot ApplicableNCT06313450

De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

112 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with early-to-intermediate stage nasopharyngeal carcinoma (a cancer of the back of the nose and throat) who respond very well to immunotherapy plus chemotherapy before radiation can safely receive a lower dose of radiation to the primary tumor site, potentially reducing side effects. **You may be eligible if...** - You are between 18 and 70 years old - You have pathologically confirmed nasopharyngeal carcinoma that has not yet been treated - Your cancer is stage II or III (excluding early T2N0 stage) - You have acceptable blood counts, liver, and kidney function - Your general health score (ECOG PS) is 0 or 1 **You may NOT be eligible if...** - You have already received any cancer treatment for this diagnosis - You have a very early or very advanced stage of disease outside the study criteria - Your blood counts or organ function (liver, kidneys) are outside acceptable ranges - You are unwilling or unable to comply with the study visits and treatment plan 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

RADIATIONde-escalated radiotherapy

Enrolled patients receive three courses of induction therapy with gemcitabine and cisplatin, along with Toripalimab. After induction therapy, patients with a tumor volume regression of 75% or more and no detectable EBV DNA will receive de-escalated radiotherapy for the primary tumor with 60 Gy. During radiotherapy, patients will receive Cisplatin 100 mg/m2 every three weeks for two courses and Toripalimab 240 mg every three weeks for three courses. If patients do not achieve complete remission at the end of radiotherapy, 6 Gy will be added to the residual lesions.

RADIATIONconventional radiotherapy

Enrolled patients receive three courses of induction therapy with gemcitabine and cisplatin, along with Toripalimab. After induction therapy, patients with tumor volume regression less than 75% or EBV DNA copy number higher than 0 receive conventional radiotherapy for the primary tumor with 70 Gy. Patients will receive Cisplatin 100 mg/m2, every three weeks for two courses during radiotherapy.


Locations(1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06313450


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