RecruitingPhase 2NCT05213884

The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC

A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma


Sponsor

Chongqing University Cancer Hospital

Enrollment

30 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding camrelizumab (an immunotherapy drug) before and after standard chemoradiation therapy improves outcomes for people with locally advanced head and neck squamous cell carcinoma (HNSCC) — cancers of the mouth, throat, voice box, or nasal passages that cannot be surgically removed. **You may be eligible if...** - You are 18 years old or older - You have a confirmed diagnosis of squamous cell carcinoma of the lip, oral cavity, throat (oropharynx or hypopharynx), voice box, or nasal sinus - Your cancer is stage III, IVa, or IVb (or stage III for HPV-positive throat cancer) - You cannot have surgery or have declined it, but are eligible for chemoradiation - Your tumor can be measured on CT or MRI scan - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have had prior immunotherapy treatment (PD-1, PD-L1, or CTLA-4 drugs) - You have an active autoimmune disease requiring treatment - You have active hepatitis B or C - You are pregnant or breastfeeding - You have a history of immunodeficiency or organ transplantation 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

200 mg, intravenous infusion over 30 minutes (Q3W); 1\~3 cycles of camrelizumab before radiotherapy and camrelizumab are maintained for 16 cycles (1 year) after the end of radiotherapy.

DRUGConcurrent cisplatin chemotherapy

cisplatin is given at a dose of 40 mg/m2 via intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy every week for 6 cycles.

RADIATIONIntensity-modulated radiotherapy (IMRT)

70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.


Locations(3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital

Wanzhou, Chongqing Municipality, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT05213884


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