RecruitingPhase 3NCT06675214

Under Whole-course of Immunotherapy, Gradient Fractionated RT with CCT Versus CFRT with CCT for LANPC Who Achieved PR Post Induction Chemotherapy.

Under Whole-course of Immunotherapy, Gradient Fractionated Radiotherapy with Concurrent Chemotherapy Versus Standard Fractionated Radiotherapy with Concurrent Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Partial Response After Induction Chemotherapy: a Randomized, Open-label, Multicenter, Phase III Trial.


Sponsor

Sun Yat-sen University

Enrollment

586 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1 ratio to receive gradient radiotherapy (reducing the irradiation dose of PET-CT areas without metabolic abnormalities, while maintaining adequate irradiation dose of areas with metabolic abnormalities) or standard dose radiotherapy with concurrent chemotherapy. It is expected to provide a new therapeutic option for locally advanced nasopharyngeal carcinoma at moderate risk.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation therapy approaches for patients with locally advanced nasopharyngeal cancer (cancer at the back of the nose/throat) who partially responded to initial chemotherapy plus immunotherapy. Both groups continue immunotherapy throughout. The question is whether using a gradual, varying dose schedule (gradient fractionated RT) is better than a standard dose schedule (conventional fractionated RT). **You may be eligible if...** - You have confirmed locally advanced nasopharyngeal carcinoma (stage III–IVA) - You achieved a partial response (shrinkage but not complete disappearance) after 3 cycles of platinum-based chemotherapy plus immunotherapy - You are between 18 and 65 years old - Your general health score (ECOG) is 0 or 1 and your organ function is adequate **You may NOT be eligible if...** - Your cancer did not respond to induction therapy - You have significant heart, liver, or kidney problems - You are pregnant or unwilling to use contraception 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

DRUGFull course of PD-1/PD-L1 blockades

a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.

DRUGCisplatin-based induction chemotherapy

Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

RADIATIONStandard-dose IMRT

GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82y CTV2: 54.12Gy/33Fr/1.64Gy

RADIATIONGradient Fractionated IMRT

GTVresidue: 68Gy/30Fr/2.27Gy GTVmcr: 60Gy/30F/2Gy CTV1:54Gy/30F/1.8Gy CTV2: 48GY/30F/1.60Gy

DRUGConcurrent Chemotherapy

Cisplatin 100mg/m2 every 3 weeks for 2 cycles


Locations(1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

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NCT06675214


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