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Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma

Primary Purpose

Locally Advanced Head and Neck Squamous Cell Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sign informed consent; Age ≥ 18 years, regardless of gender; Histology or cytology confirmed head and neck squamous cell carcinoma, HNSCC (Oral cavity, oropharynx, larynx and hypopharynx), and previously untreated; Imaging confirmed that HNSCC was locally advanced and operable; Imaging confirmed no metastasis; ECOG physical status score 0-1; Life expectancy at least 24 weeks; Have measurable lesions; Good function of other major organs (liver, kidney, blood system, etc.): Absolute neutrophil count ((ANC) ≥ 1.0×10^9), platelet (≥ 80×10^9), hemoglobin (≥ 80g/L). Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN; Female patients with fertility must undergo a pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 120 days after the last administration; Male patients must voluntarily take effective contraceptive measures from the start of treatment until 120 days after the last administration. Exclusion Criteria: Pregnant or breastfeeding, or planning to become pregnant during the study period Patients with active autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, positive HIV test or a history of the above diseases, or a history of organ transplantation; Receiving systemic immunosuppressive drugs within 2 weeks before starting study treatment, or anticipating the need for systemic immunosuppressive drugs during study treatment; Received systemic immunostimulants (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks before starting study treatment; History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ; Serious cardiovascular disease, unstable arrhythmia, or unstable angina pectoris within 3 months before starting study treatment; The subject has an active infection or infectious disease, or unexplained fever (body temperature > 38.5℃) during screening and before the first dose; Patients who have received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting study treatment; patients receiving prophylactic antibiotic therapy (e.g., prophylaxis for urinary tract infection or chronic obstructive pulmonary - Untreated active hepatitis; Receiving immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment; Received chemotherapy or targeted therapy within 4 weeks before enrollment; The subject has participated in or completed other clinical trials within 4 weeks before enrollment; Subjects may need to receive other anti-tumor therapy during the study; Subjects may need to receive a vaccine during the study or within 4 weeks prior to enrollment.

Sites / Locations

  • Tianjin Medical University Cancer Institute and Hospital
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Toripalimab + SBRT radiotherapy

Outcomes

Primary Outcome Measures

Major pathological response (MPR)
Percentage of Participants with MPR. MPR is defined as > 90 percent decrease in viable tumor.

Secondary Outcome Measures

Pathological Complete Response (pCR)
Percentage of Participants with pCR. pCR is defined as the absence of residual tumor in both primary tumor and lymph nodes after neoadjuvant treatment.
Frequency and severity of perioperative adverse events
Grade 2-5 AEs according to NCI-CTCAE V5.0
Quality of life questionnaires
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

Full Information

First Posted
April 27, 2023
Last Updated
May 16, 2023
Sponsor
Tianjin Medical University General Hospital
Collaborators
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05861557
Brief Title
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official Title
A Prospective Phase II Trial to Evaluate the Safety and Efficacy of Neoadjuvant Radiotherapy Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2023 (Anticipated)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
May 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital
Collaborators
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.
Detailed Description
After receiving one cycle of immunotherapy, the subjects underwent SBRT radiotherapy to the lesion, followed by another cycle of immunotherapy. Surgery was performed 3-6 weeks later, and subsequent radiotherapy or chemoradiotherapy was decided after surgery based on pathological examination. Immunotherapy was maintained for 6 months. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by the principal investigator, whichever occurred first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Toripalimab + SBRT radiotherapy
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
240mg, Q3W,I.V., D1, 2 cycles (1cycle of toripalimab before and after the SBRT radiotherapy, respectively), followed by the maintenance of toripalimab for 6 months after the surgery.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
Subjects were treated with SBRT radiotherapy (8Gy*5Fx), after 1 cycle of immunotherapy
Primary Outcome Measure Information:
Title
Major pathological response (MPR)
Description
Percentage of Participants with MPR. MPR is defined as > 90 percent decrease in viable tumor.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Pathological Complete Response (pCR)
Description
Percentage of Participants with pCR. pCR is defined as the absence of residual tumor in both primary tumor and lymph nodes after neoadjuvant treatment.
Time Frame
up to 6 months
Title
Frequency and severity of perioperative adverse events
Description
Grade 2-5 AEs according to NCI-CTCAE V5.0
Time Frame
up to 6 months
Title
Quality of life questionnaires
Description
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign informed consent; Age ≥ 18 years, regardless of gender; Histology or cytology confirmed head and neck squamous cell carcinoma, HNSCC (Oral cavity, oropharynx, larynx and hypopharynx), and previously untreated; Imaging confirmed that HNSCC was locally advanced and operable; Imaging confirmed no metastasis; ECOG physical status score 0-1; Life expectancy at least 24 weeks; Have measurable lesions; Good function of other major organs (liver, kidney, blood system, etc.): Absolute neutrophil count ((ANC) ≥ 1.0×10^9), platelet (≥ 80×10^9), hemoglobin (≥ 80g/L). Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN; Female patients with fertility must undergo a pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 120 days after the last administration; Male patients must voluntarily take effective contraceptive measures from the start of treatment until 120 days after the last administration. Exclusion Criteria: Pregnant or breastfeeding, or planning to become pregnant during the study period Patients with active autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, positive HIV test or a history of the above diseases, or a history of organ transplantation; Receiving systemic immunosuppressive drugs within 2 weeks before starting study treatment, or anticipating the need for systemic immunosuppressive drugs during study treatment; Received systemic immunostimulants (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks before starting study treatment; History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ; Serious cardiovascular disease, unstable arrhythmia, or unstable angina pectoris within 3 months before starting study treatment; The subject has an active infection or infectious disease, or unexplained fever (body temperature > 38.5℃) during screening and before the first dose; Patients who have received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting study treatment; patients receiving prophylactic antibiotic therapy (e.g., prophylaxis for urinary tract infection or chronic obstructive pulmonary - Untreated active hepatitis; Receiving immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment; Received chemotherapy or targeted therapy within 4 weeks before enrollment; The subject has participated in or completed other clinical trials within 4 weeks before enrollment; Subjects may need to receive other anti-tumor therapy during the study; Subjects may need to receive a vaccine during the study or within 4 weeks prior to enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huifang Zhou, Dr.
Phone
+86-22-60814958
Email
zyyzhf@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ximei Zhang, Dr.
Phone
+86-22-23340123
Email
xiangrikuigirl@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huifang Zhou
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ximei Zhang
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ximei Zhang
Phone
+86-22-23340123
Email
xiangrikuigirl@126.com
First Name & Middle Initial & Last Name & Degree
Ximei Zhang, Dr.
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Zhou
Phone
+86 022-60814958
Email
zyyzhf@163.com
First Name & Middle Initial & Last Name & Degree
Huifang Zhou, Dr.

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma

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