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

Head and Neck Squamous Cell Carcinoma

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

Inclusion Criteria10

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 Criteria8

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.

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.