A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Sponsor
- Chongqing University Cancer Hospital
- Enrollment
- 39
- Locations
- 6
- Primary Endpoint
- EFFICACY Progress-free survival (PFS)
- Status
- Completed
- Last Updated
- 8 days ago
Overview
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.
Investigators
Ying Wang
Associate Director of Chongqing University Cancer Hospital
Chongqing University Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Males and females ≥18 years of age.
- •ECOG Performance Status 0 or
- •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.
Arms & Interventions
Camrelizumab plus chemoradiotherapy
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.
Intervention: Camrelizumab
Camrelizumab plus chemoradiotherapy
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.
Intervention: Concurrent cisplatin chemotherapy
Camrelizumab plus chemoradiotherapy
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.
Intervention: Intensity-modulated radiotherapy (IMRT)
Outcomes
Primary Outcomes
EFFICACY Progress-free survival (PFS)
Time Frame: 2 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Secondary Outcomes
- EFFICACY Objective response rate (ORR）(2 years)
- EFFICACY Duration of response (DOR)(2 years)
- SAFETY Incidence rate of adverse events (AEs)(2 years)
- QUALITY OF LIFE Quality of life (QoL): questionnaire(2 years)
- EFFICACY Overall survival (OS)(2 years)