Status:
UNKNOWN
Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC
Lead Sponsor:
Xingchen Peng
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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);
- BNP \<=ULN;
- T3 \<=ULN and T4 \<=ULN after treatment;
- Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment; For female subjects with reproductive potential: a negative serum pregnancy test;
- Have signed consent form.
Exclusion
- 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;
- Treatment with oral or parenteral corticosteroids (\>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy;
- Treatment with anti-tumor vaccine or live vaccines within 4 weeks
- Surgery or severe trauma within 4 weeks;
- Active infection;
- Active autoimmune disease;
- History of immunodeficiency, including HIV antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- History of noninfectious pneumonia;
- Active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment;
- Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody and HCV-RNA positive;
- History of alcoholism and drug abuse;
- Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
- Patients are pregnant or breast-feeding;
- Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04399785
Start Date
June 1 2020
End Date
June 1 2022
Last Update
May 22 2020
Active Locations (1)
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1
Xingchen Peng
Chengdu, Sichuan, China, 610041