NCT04399785

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

May 16, 2020

Last Update Submit

May 19, 2020

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Anti-PD-1 InhibitorStereotacic RadiotherapyHead and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective Response Rate

    up to approximately 2 years

Secondary Outcomes (4)

  • PFS

    up to approximately 2 years

  • OS

    up to approximately 2 years

  • DOR

    up to approximately 2 years

  • AE

    from the first drug administration to within 30 days for the last therapy

Study Arms (1)

Arm 1

EXPERIMENTAL
Other: Camrelizumab and SBRT

Interventions

Camrelizumab and SBRTOTHER

Camrelizumab: 200mg every 3 weeks; SBRT

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xingchen Peng

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumabRadiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Xingchen Peng, Dr

CONTACT

+86 18980606753pxx2014@scu.edu.cn

Yan Li, Dr

CONTACT

+862885422591yy1240@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Combination of camrelizumab and stereotacic radiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 22, 2020

Study Start

June 1, 2020

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

CN(1)