Phase II Study for Combination of Camrelizumab and Stereotacic Radiotherapy in the First-line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Xingchen Peng1 site in 1 country34 target enrollmentJune 1, 2020

ConditionsHead and Neck Squamous Cell Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Xingchen Peng
Enrollment: 34
Locations: 1
Primary Endpoint: ORR
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, single-center, open-label, phase II clinical study for patients with recurrent or metastatics quamous cell carcinoma of the head and neck.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

June 1, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xingchen Peng

Responsible Party

Sponsor Investigator

Principal Investigator

Xingchen Peng

Associate professor

West China Hospital

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed squamous cell carcinoma of the head and neck;
•Patients with untreated recurrent or metastatic disease;
•Combined positive Score\>=1;
•Aged \>=18 years;
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•At least one measurable lesion, according to RECIST 1.1;
•Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion):
•HB\>=80g/L, ANC\>=1.5x10\^9/L, PLT \>=80x10\^9/L;
•TBIL\<=1.5 ULN, ALT and AST \<=2.5 ULN, if there exists hepatic metastases, ALT and AST \<=5 ULN, Cr \<=1.5 ULN or CCr \>=60ml/min;
•INR or PT \<= 1.5 ULN, APTT \<=1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range);

Exclusion Criteria

•Have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ;
•Known allergic reactions to the components of PD-1 monoclonal antibody;
•Central nervous system metastasis with symptoms;
•Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4 within 2 weeks.
•Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
•Ischemic cardiovascular events occurred within 1 year prior to the start of treatment;
•ECG QT interval \>500ms;
•Patients are receiving immunosuppressive therapy;
•Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4;
•Treatment with an investigational agent within 4 weeks;