Clinical trial NCT04399785: Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Anti-PD-1 Inhibitor
Stereotacic Radiotherapy
Head and Neck Squamous Cell Carcinoma
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2020-05-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combination of camrelizumab and stereotacic radiotherapy
Primary purpose: TREATMENT

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 Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck;
2. Patients with untreated recurrent or metastatic disease;
3. Combined positive Score\>=1;
4. Aged \>=18 years;
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
6. At least one measurable lesion, according to RECIST 1.1;
7. Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion):

   1. HB\>=80g/L, ANC\>=1.5x10\^9/L, PLT \>=80x10\^9/L;
   2. 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;
   3. 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);
   4. BNP \<=ULN;
   5. T3 \<=ULN and T4 \<=ULN after treatment;
8. 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;
9. Have signed consent form.

Exclusion Criteria:

1. Have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ;
2. Known allergic reactions to the components of PD-1 monoclonal antibody;
3. Central nervous system metastasis with symptoms;
4. Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4 within 2 weeks.
5. Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
6. Ischemic cardiovascular events occurred within 1 year prior to the start of treatment;
7. ECG QT interval \>500ms;
8. Patients are receiving immunosuppressive therapy;
9. Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4;
10. Treatment with an investigational agent within 4 weeks;
11. Treatment with oral or parenteral corticosteroids (\>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy;
12. Treatment with anti-tumor vaccine or live vaccines within 4 weeks
13. Surgery or severe trauma within 4 weeks;
14. Active infection;
15. Active autoimmune disease;
16. History of immunodeficiency, including HIV antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
17. History of noninfectious pneumonia;
18. Active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment;
19. Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody and HCV-RNA positive;
20. History of alcoholism and drug abuse;
21. Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
22. Patients are pregnant or breast-feeding;
23. Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.

Primary outcomes:
measure: ORR
timeFrame: up to approximately 2 years
Secondary outcomes:
measure: PFS
timeFrame: up to approximately 2 years
measure: OS
timeFrame: up to approximately 2 years
measure: DOR
timeFrame: up to approximately 2 years
measure: AE
timeFrame: from the first drug administration to within 30 days for the last therapy
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Xingchen Peng
state: Sichuan
Study officials:
References: