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

Study Overview
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Brief Summary
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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.

Detailed Description
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All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4 6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

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

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: Concurrent cisplatin chemotherapy
* Radiation: Intensity-modulated radiotherapy (IMRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥18 years of age. ECOG Performance Status 0 or 1. Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus. Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease. Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy. With measurable target lesions by CT or MRI. Adequate bone marrow function. Adequate renal and liver function. Pregnancy test (for patients of childbearing potential) negative at screening. Signed Written Informed Consent. Exclusion Criteria: Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded). Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment. Pregnancy or breast feeding. Has a history of psychiatric substance abuse, alcoholism, or drug addiction. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent. Has received a live vaccine within 4 weeks of planned start of study therapy. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camrelizumab plus chemoradiotherapy<br>Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4 6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity. | Drug: Camrelizumab<br>* 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.<br>* Other names: Anti-PD-1 antibody;Drug: Concurrent cisplatin chemotherapy<br>* 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.<br>Radiation: Intensity-modulated radiotherapy (IMRT)<br>* 70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY Progress-free survival (PFS) | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY Overall survival (OS) | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive. | 2 years | 
| EFFICACY Objective response rate (ORR） | Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause. | 2 years | 
| EFFICACY Duration of response (DOR) | Defined as the time from the first assessment of CR or PR to the first assessment of disease progression or death due to any cause. | 2 years | 
| SAFETY Incidence rate of adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0. | 2 years | 
| QUALITY OF LIFE Quality of life (QoL): questionnaire | QoL is evaluated with the use of the head-and-neck-specific module (H&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Camrelizumab, Locally Advanced HNSCC, Chemoradiotherapy