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

NCT05861557 | Unknown Phase 2

• 1 other identifier: 2023HNRT01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathological response (MPR)

  Percentage of Participants with MPR. MPR is defined as \> 90 percent decrease in viable tumor.

  up to 6 months

Secondary Outcomes (3)

• Pathological Complete Response (pCR)

  up to 6 months

• Frequency and severity of perioperative adverse events

  up to 6 months

• Quality of life questionnaires

  up to 1 year

Study Arms (1)

Experimental arm

EXPERIMENTAL

Toripalimab + SBRT radiotherapy

Drug: Toripalimab; Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Toripalimab DRUG

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.

Experimental arm

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Subjects were treated with SBRT radiotherapy (8Gy\*5Fx), after 1 cycle of immunotherapy

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (2)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

MeSH Terms

Interventions

toripalimab; Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Huifang Zhou

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

• Ximei Zhang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifang Zhou, Dr.

CONTACT

+86-22-60814958; zyyzhf@163.com

Ximei Zhang, Dr.

CONTACT

+86-22-23340123; xiangrikuigirl@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Otorhinolaryngology Department

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 17, 2023
• Study Start: May 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2025
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

CN (2)