Back to resultsThe Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Concurrent cisplatin chemotherapy
Intensity-modulated radiotherapy (IMRT)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Camrelizumab, Locally Advanced HNSCC, Chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥18 years of age.
- ECOG Performance Status 0 or 1.
- Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
- Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
- Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
- With measurable target lesions by CT or MRI.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Pregnancy test (for patients of childbearing potential) negative at screening.
- Signed Written Informed Consent.
Exclusion Criteria:
- Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
- Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
- Pregnancy or breast feeding.
- Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
Sites / Locations
- Chongqing University Cancer HospitalRecruiting
- Chongqing University Three Gorges HospitalRecruiting
- The Affiliated Hospital of Southwest Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab plus chemoradiotherapy
Arm Description
Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
EFFICACY Progress-free survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Secondary Outcome Measures
EFFICACY Overall survival (OS)
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
EFFICACY Objective response rate (ORR）
Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause.
EFFICACY Duration of response (DOR)
Defined as the time from the first assessment of CR or PR to the first assessment of disease progression or death due to any cause.
SAFETY Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0.
QUALITY OF LIFE Quality of life (QoL): questionnaire
QoL is evaluated with the use of the head-and-neck-specific module (H&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Full Information
NCT ID
NCT05213884
First Posted
January 16, 2022
Last Updated
May 4, 2023
Sponsor
Chongqing University Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05213884
Brief Title
The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC
Official Title
A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.
Detailed Description
All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Camrelizumab, Locally Advanced HNSCC, Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab plus chemoradiotherapy
Arm Type
Experimental
Arm Description
Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
Anti-PD-1 antibody
Intervention Description
200 mg, intravenous infusion over 30 minutes (Q3W); 1~3 cycles of camrelizumab before radiotherapy and camrelizumab are maintained for 16 cycles (1 year) after the end of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Concurrent cisplatin chemotherapy
Intervention Description
cisplatin is given at a dose of 40 mg/m2 via intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy every week for 6 cycles.
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy (IMRT)
Intervention Description
70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.
Primary Outcome Measure Information:
Title
EFFICACY Progress-free survival (PFS)
Description
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
EFFICACY Overall survival (OS)
Description
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
Time Frame
2 years
Title
EFFICACY Objective response rate (ORR）
Description
Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause.
Time Frame
2 years
Title
EFFICACY Duration of response (DOR)
Description
Defined as the time from the first assessment of CR or PR to the first assessment of disease progression or death due to any cause.
Time Frame
2 years
Title
SAFETY Incidence rate of adverse events (AEs)
Description
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time Frame
2 years
Title
QUALITY OF LIFE Quality of life (QoL): questionnaire
Description
QoL is evaluated with the use of the head-and-neck-specific module (H&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥18 years of age.
ECOG Performance Status 0 or 1.
Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
With measurable target lesions by CT or MRI.
Adequate bone marrow function.
Adequate renal and liver function.
Pregnancy test (for patients of childbearing potential) negative at screening.
Signed Written Informed Consent.
Exclusion Criteria:
Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
Pregnancy or breast feeding.
Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
Has received a live vaccine within 4 weeks of planned start of study therapy.
Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhang, Ph.D, M.D.
Phone
18323063006
Email
zhangxin9964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang, Ph.D, M.D.
Phone
13996412826
Email
yingwang197011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Wang, Ph.D, M.D.
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhang, Ph.D, M. D.
Phone
18323064006
Email
zhangxin9964@126.com
First Name & Middle Initial & Last Name & Degree
Ying Wang, Ph.D, M. D.
Phone
13996412826
Email
yingwang197011@163.com
First Name & Middle Initial & Last Name & Degree
Ying Wang, Ph.D, M. D.
First Name & Middle Initial & Last Name & Degree
Xin Zhang, Ph.D, M. D.
Facility Name
Chongqing University Three Gorges Hospital
City
Wanzhou
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Zhu, M.D
Phone
13983505825
Email
981149098@qq.com
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun He, M.D
Phone
0830-3165273
Email
xnydhh@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of Induction and Adjuvant Camrelizumab Combined With Chemoradiation for LA-HNSCC
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