Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT05861557
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Toripalimab and Stereotactic Body Radiation Therapy (SBRT) in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Tianjin Medical University General Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Toripalimab and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesChina
- Study dates
- 20 May 2023to 20 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Ximei Zhang, +86-22-23340123, xiangrikuigirl@126.com
Ximei Zhang, Dr.
Tianjin Medical University General Hospital
Tianjin
Huifang Zhou, +86 022-60814958, zyyzhf@163.com
Huifang Zhou, Dr.
About this study
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
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.
Read the 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.
- Being tested
- Toripalimab, Stereotactic Body Radiation Therapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
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.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Subjects were treated with SBRT radiotherapy (8Gy*5Fx), after 1 cycle of immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Toripalimab + SBRT radiotherapy Receives: Drug: Toripalimab; Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR)
Percentage of Participants with MPR. MPR is defined as > 90 percent decrease in viable tumor.
Measured: up to 6 months
Secondary outcomes (3)
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.
Measured: up to 6 months
Frequency and severity of perioperative adverse events
Grade 2-5 AEs according to NCI-CTCAE V5.0
Measured: up to 6 months
Quality of life questionnaires
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start20 May 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Huifang, Tianjin Medical University General Hospital
- Investigators
- Huifang Zhou, Principal investigator, Tianjin Medical University General HospitalXimei Zhang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861557
- Sponsor's protocol ID
- 2023HNRT01
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05861557
- Acronym / sponsor ID
- 2023HNRT01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Toripalimab, Radiation: Stereotactic Body Radiation Therapy (SBRT)Toripalimab + SBRT radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab240mg, 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. | Drug | Experimental arm |
| Stereotactic Body Radiation Therapy (SBRT)Subjects were treated with SBRT radiotherapy (8Gy*5Fx), after 1 cycle of immunotherapy | Radiation | Experimental arm |
Primary outcome
Major pathological response (MPR)
Time frame: up to 6 months
Percentage of Participants with MPR. MPR is defined as > 90 percent decrease in viable tumor.
3 secondary outcomes
Pathological Complete Response (pCR)
Time frame: up to 6 months
Frequency and severity of perioperative adverse events
Time frame: up to 6 months
Quality of life questionnaires
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huifang Zhou principal investigator
Tianjin Medical University General Hospital
Ximei Zhang principal investigator
Tianjin Medical University Cancer Institute and Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab and Stereotactic Body Radiation Therapy (SBRT) in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Tianjin Medical University General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huifang Zhou, Dr. (+86-22-60814958, zyyzhf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.