RecruitingPhase 2NCT06349889

Adebrelimab and Chemoradiotherapy in High-risk LANPC

Adebrelimab Combined with Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 2, Multicenter, Single-arm Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called adebrelimab to the standard chemotherapy-plus-radiation treatment improves outcomes for people with high-risk, locally advanced nasopharyngeal carcinoma (a type of head and neck cancer). **You may be eligible if...** - You have a confirmed diagnosis of nasopharyngeal carcinoma (a type of cancer at the back of the nose/throat) - Your cancer is staged as IVA or T3N2M0 (meaning locally advanced but not spread to distant organs) - You are in good general health (ECOG performance status 0 or 1) - Your blood counts, liver function, and kidney function are within acceptable ranges - Women of childbearing potential must agree to use effective contraception **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have serious organ dysfunction (liver, kidney, heart, or bone marrow problems) - You are pregnant or breastfeeding - You have active autoimmune disease 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

DRUGAdebrelimab

Drug: Adebrelimab Adebrelimab 1200mg 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. Other Names: PD-L1 antibody Drug: Gemcitabine Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. Other Names: GEM Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation Other Names: DDP Radiation: Intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. Other Names: IMRT


Locations(4)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06349889


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