Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399785
• Other study ID #: CART0326
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2020
• Source: West China Hospital
• Contact: Xingchen Peng, Dr
• Phone: +86 18980606753
• Email: pxx2014[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Camrelizumab and SBRT
Camrelizumab: 200mg every 3 weeks; SBRT

Locations

Country	Name	City	State
China	Xingchen Peng	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Xingchen Peng	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	up to approximately 2 years
Secondary	PFS	Progression-Free-Survival	up to approximately 2 years
Secondary	OS	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up	up to approximately 2 years
Secondary	DOR	Disease Control Rate	up to approximately 2 years
Secondary	AE	Adverse Events	from the first drug administration to within 30 days for the last therapy