Head and Neck CancerPhase 2NCT05595590
Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer
A Phase 2 study testing Tislelizumab and Pulse radiation in people with Head and Neck Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Tislelizumab and Pulse radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2022to 19 Oct 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed squamous cell head and neck cancer, A karnofsky performance status≥70.
- Previous radical therapy (surgery ± chemoradiotherapy or radical chemoradiotherapy) and the records of radiation fields and dosage of previous treatment can be obtained.
- Inoperable or completely resectable under MDT consultation.
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
- Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
Who cannot join
- Pregnant or breastfeeding, or planning to become pregnant during the study period
- The patient had another malignant tumor expcet HNSCC
- Have an active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, test positive for HIV or have a history of any of these diseases, or have a history of organ transplantation;
- They had received reradiotherapy within 1 month prior to entering the study
- Receiving systemic immunosuppressive drugs within 2 weeks prior to commencing study treatment, or anticipating needing systemic immunosuppressive drugs during study treatment;
- having received systemic immune-stimulating agents (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to study treatment initiation or remaining within 5 half-lives (whichever is longer);
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- A history of other malignancies within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ;
- Severe cardiovascular disease (e.g., New York College of Cardiology heart disease class Ⅱ or greater, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months before commences study treatment;
- The subject has an active infection or infectious disease, or develops a fever of unknown origin (body temperature >38.5 ° C) during screening and before the first dose;
- had received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting the study; Patients receiving prophylactic antibiotic therapy, such as prevention of urinary tract infection or chronic obstructive pulmonary disease, were enrolled.
- Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA≥104ml; Hepatitis C: HCV-RNA≥103/ml or antiviral therapy required during the study);
- Immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment.
- Chemotherapy or targeted therapy within 4 weeks prior to enrollment;
- Subjects have participated in or completed other clinical trials within 4 weeks prior to enrollment;
- Subjects may need to receive other antitumor treatments during the study;
- Subjects may need to have been vaccinated during the study or within 4 weeks prior to enrollment.
- A patient who, in the investigator's judgment, has other comorbidities that seriously jeopardize the patient's safety or interfere with the patient's completion of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sichuan Cancer Hosiptal
Chengdu, Sichuan
Peng Zhang, Dr., +86-28-85420897
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Ximei Zhang, Dr., +86-22-23340123
About this study
Official title: Phase II Trial of Pulsed Radiotherapy Combined With Tislelizumab in Patients With Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma
The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC).
- Conditions
- Head and Neck Cancer
- Being tested
- Tislelizumab, Pulse radiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Administered as an intravenous (IV) infusion 200mg every 3 weeks (Q3W)
Pulse radiationRadiation
66-70Gy/33-35Fx, 2Gy/Fx.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab + Pulse radiation | Experimental | Participants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy. Receives: Drug: Tislelizumab; Radiation: Pulse radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) using iRECIST 1.1 criteria
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with RT, referred to as "Target lesion (RT+ Tisle), as well as the lesion(s) not treated with RT (if applicable), referred to as "Target lesion (Tisle only)", per the prescribed treatment.
Measured: From time of first dose of study treatment until disease progression or death (up to 2 years)
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Measured: From time of first dose of study treatment until the end of follow-up (up to 2 years)
Secondary outcomes (3)
Duration of Response (DOR)
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Measured: From time of first dose of study treatment until disease progression or death (up to 2 years)
Progression Free Survival (PFS)
PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.
Measured: From time of first dose of study treatment until disease progression or death (up to 2 years)
Change From Baseline Quality of Life (GHS/QoL)
Change from baseline in QoL using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H\&N35)
Measured: From time of first dose of study treatment until disease progression or death (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion19 Oct 2024 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ximei Zhang, Dr., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595590
- Sponsor's protocol ID
- E20220816
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pulsed Radiotherapy Combined With Tislelizumab in Patients With Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05595590
- Acronym / sponsor ID
- E20220816
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 19 Oct 2024 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 27 Oct 2022 (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.
The purpose of this study is to determine the efficacy and safety of pulsed radiotherapy given concomitantly with Tislelizumab and as maintenance therapy in participants with locoregionally recurrent head and neck squamous cell carcinoma ( HNSCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab + Pulse radiation | Experimental | Drug: Tislelizumab, Radiation: Pulse radiationParticipants receive pulsed radiationtherapy concurrent with 3 cycles of Tislelizumab followed by an additional 32 cycles of Tislelizumab alone as maintenance therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed squamous cell head and neck cancer, A karnofsky performance status≥70.
- Previous radical therapy (surgery ± chemoradiotherapy or radical chemoradiotherapy) and the records of radiation fields and dosage of previous treatment can be obtained.
- Inoperable or completely resectable under MDT consultation.
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Key exclusion criteria (17 listed)
- Pregnant or breastfeeding, or planning to become pregnant during the study period
- The patient had another malignant tumor expcet HNSCC
- Have an active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, test positive for HIV or have a history of any of these diseases, or have a history of organ transplantation;
- They had received reradiotherapy within 1 month prior to entering the study
- Receiving systemic immunosuppressive drugs within 2 weeks prior to commencing study treatment, or anticipating needing systemic immunosuppressive drugs during study treatment;
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 |
|---|---|---|
| TislelizumabAdministered as an intravenous (IV) infusion 200mg every 3 weeks (Q3W) | Drug | Tislelizumab + Pulse radiation |
| Pulse radiation66-70Gy/33-35Fx, 2Gy/Fx. | Radiation | Tislelizumab + Pulse radiation |
Primary outcome
Objective response rate (ORR) using iRECIST 1.1 criteria
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with RT, referred to as "Target lesion (RT+ Tisle), as well as the lesion(s) not treated with RT (if applicable), referred to as "Target lesion (Tisle only)", per the prescribed treatment.
Adverse Events (AEs)
Time frame: From time of first dose of study treatment until the end of follow-up (up to 2 years)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
3 secondary outcomes
Duration of Response (DOR)
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Progression Free Survival (PFS)
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Change From Baseline Quality of Life (GHS/QoL)
Time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Ximei Zhang, Dr. 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 Tislelizumab and Pulse radiation in people with Head and Neck Cancer, run by Tianjin Medical University Cancer Institute and 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 6 inclusion and 17 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 27 Oct 2022. 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 Ximei Zhang, Dr. (+86-22-23340123, xiangrikuigirl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) using iRECIST 1.1 criteria (time frame: From time of first dose of study treatment until disease progression or death (up to 2 years)). The study lists 2 primary outcomes in all. 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 27 Oct 2022.