Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Camrelizumab, Locally Advanced HNSCC, Chemoradiotherapy
Brief 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.
Detailed description
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.
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.
70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females ≥18 years of age. 2. ECOG Performance Status 0 or 1. 3. Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus. 4. Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease. 5. Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy. 6. With measurable target lesions by CT or MRI. 7. Adequate bone marrow function. 8. Adequate renal and liver function. 9. Pregnancy test (for patients of childbearing potential) negative at screening. 10. Signed Written Informed Consent.
Exclusion criteria
1. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. 2. Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded). 3. Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment. 4. Pregnancy or breast feeding. 5. Has a history of psychiatric substance abuse, alcoholism, or drug addiction. 6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent. 7. Has received a live vaccine within 4 weeks of planned start of study therapy. 8. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY Progress-free survival (PFS) | 2 years | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY Overall survival (OS) | 2 years | Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive. |
| EFFICACY Objective response rate (ORR） | 2 years | Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause. |
| EFFICACY Duration of response (DOR) | 2 years | 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. |
| SAFETY Incidence rate of adverse events (AEs) | 2 years | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYing Wang, Ph.D, M.D.
Chongqing University Cancer Hospital
Outcome results
None listed