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

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

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Camrelizumab and SBRT

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xingchen Peng, Dr; Phone Number: +86 18980606753; Email: pxx2014@scu.edu.cn
• Study Contact Backup: Name: Yan Li, Dr; Phone Number: +862885422591; Email: yy1240@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Xingchen Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Other: Camrelizumab and SBRT; Camrelizumab: 200mg every 3 weeks; SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free-Survival	up to approximately 2 years
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
DOR	Disease Control Rate	up to approximately 2 years
AE	Adverse Events	from the first drug administration to within 30 days for the last therapy

Collaborators and Investigators

• Sponsor: Xingchen Peng
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 16, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Head and Neck Squamous Cell Carcinoma; Anti-PD-1 Inhibitor; Stereotacic Radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CART0326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No