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

NCT ID: NCT04399785

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-06-01

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Camrelizumab and SBRT

Intervention Type: OTHER

Camrelizumab: 200mg every 3 weeks; SBRT

Interventions

Camrelizumab and SBRT

Camrelizumab: 200mg every 3 weeks; SBRT

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xingchen Peng

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xingchen Peng

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingchen Peng, Dr

Role: CONTACT

pxx2014@scu.edu.cn

+86 18980606753

Yan Li, Dr

Role: CONTACT

yy1240@163.com

+862885422591

Facility Contacts

Xingchen Peng

Role: primary

pxx2014@scu.edu.cn

+86 18980606753

Other Identifiers

CART0326

Identifier Type: -

Identifier Source: org_study_id