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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861557
• Other study ID #: 2023HNRT01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 20, 2023
• Est. completion date: May 20, 2025

Study information

• Verified date: May 2023
• Source: Tianjin Medical University General Hospital
• Contact: Huifang Zhou, Dr.
• Phone: +86-22-60814958
• Email: zyyzhf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: May 20, 2025
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Toripalimab
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.

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
Subjects were treated with SBRT radiotherapy (8Gy*5Fx), after 1 cycle of immunotherapy

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital	Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR)	Percentage of Participants with MPR. MPR is defined as > 90 percent decrease in viable tumor.	up to 6 months
Secondary	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.	up to 6 months
Secondary	Frequency and severity of perioperative adverse events	Grade 2-5 AEs according to NCI-CTCAE V5.0	up to 6 months
Secondary	Quality of life questionnaires	EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)	up to 1 year