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Trial Title:
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05861557
Condition:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
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.
Arm group label:
Experimental arm
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy (SBRT)
Description:
Subjects were treated with SBRT radiotherapy (8Gy*5Fx), after 1 cycle of immunotherapy
Arm group label:
Experimental arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Ximei Zhang
Phone:
+86-22-23340123
Email:
xiangrikuigirl@126.com
Investigator:
Last name:
Ximei Zhang, Dr.
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Huifang Zhou
Phone:
+86 022-60814958
Email:
zyyzhf@163.com
Investigator:
Last name:
Huifang Zhou, Dr.
Email:
Principal Investigator
Start date:
May 20, 2023
Completion date:
May 20, 2025
Lead sponsor:
Agency:
Tianjin Medical University General Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05861557
