RecruitingPhase 3NCT04453826

Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma

Sponsor

Sun Yat-sen University

Enrollment

388 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Radiotherapy Nasopharyngeal Cancer PD-1 Therapy

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (a PD-1 inhibitor) to standard chemoradiotherapy improves treatment outcomes for patients with high-risk nasopharyngeal cancer — cancer that starts at the back of the nose and throat and has specific high-risk features at diagnosis. **You may be eligible if:** - You have been diagnosed with a specific type of nasopharyngeal cancer (non-keratinizing type, WHO type II or III) - Your cancer is classified as high-risk or advanced stage (stage IVa, or stage II-III that did not respond well to initial induction chemotherapy) - You are between 18 and 70 years old - Your general health score (Karnofsky) is 70 or above - Your blood, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - You have keratinizing squamous cell carcinoma (WHO type I) - Your cancer has spread to distant organs or has come back after previous treatment - Your stage II-III cancer responded well to 3 cycles of prior induction chemotherapy - You have an active or past autoimmune disease - You have another active cancer - You have significant substance use or psychiatric history 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

DRUGCamrelizumab plus chemo-radiotherapy

1. Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy. 2. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 3. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

DRUGChemo-radiotherapy alone

1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy