RecruitingPhase 3NCT06749899

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma：A Randomized, Controlled, Multicenter Phase III Clinical Study.

Sponsor

Sun Yat-Sen University Cancer Center

Enrollment

580 participants

Start Date

May 4, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancer Nasopharyngeal Cancinoma (NPC)

Summary

The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination immunotherapy drug called QL1706 (which blocks both PD-1 and CTLA-4, two 'brakes' on the immune system) given alongside standard chemoradiotherapy, in patients with locally advanced nasopharyngeal carcinoma — a type of head and neck cancer that starts at the back of the nose near the throat. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with non-keratinizing nasopharyngeal carcinoma (a specific subtype), confirmed by biopsy - Your cancer is at a locally advanced stage (T4N1 or T1-4N2-3, based on AJCC 9th edition staging) - Your blood counts, liver function, and kidney function are within acceptable ranges - You have normal thyroid function **You may NOT be eligible if...** - You have a different subtype of nasopharyngeal cancer - Your cancer has spread distantly (metastatic disease) - Your general health is too poor for chemoradiotherapy - You have significant organ dysfunction 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

DRUGQL1706

QL1706 5mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.

DRUGGemcitabine

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

DRUGCisplatin

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

RADIATIONIntensity-modulated radiotherapy

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Locations(19)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

First People's Hospital of Foshan

Foshan, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hubei Province Cancer Hosiptal

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute ＆ Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xiamen University

Fujian, Xiamen, China

View Full Details on ClinicalTrials.gov

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NCT06749899

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