Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT06240689
A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood
A Phase 2 study testing Sintilimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 5 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female, age ≥ 18 years old, ≤ 75 years old.
- Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
- Patients undergoing concurrent chemoradiotherapy
- ECOG performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion
Show all 13Show fewer
- Blood test: absolute neutrophil count (ANC) > 1.5×109/L, hemoglobin > 8g/dL and platelet > 100 ×109/L (subject to the normal value of the clinical trial center).
- Prothrombin time (PT) <1.5 times the upper limit of normal and normal thromboplastin time (APTT) <1.5 times the upper limit of normal.
- Laboratory examination, serum creatinine less than or equal to 1.5 times the upper limit of the reference range of normal values (If serum creatinine is elevated, 24-hour urine must be collected. Except for the 24-hour creatinine clearance rate is > 50ml/min).
- In the absence of liver metastases, ALT or AST is less than or equal to 2.5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 1.5 times the upper limit of the reference range of normal values; for patients with liver metastases, ALT or AST is less than or equal to 5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 3 times of the upper limit of the reference range of normal values.
- Females of childbearing potential must be willing to use adequate contraception for the duration of study drug treatment.
- Signed informed consent.
- At the end of radiotherapy, the proportion of PD1+CD8T cells in peripheral blood is greater than 10%, or more than 2 times higher than baseline
Who cannot join
- Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.
- Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use of physiologic doses of corticosteroids may be approved.
- Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative therapy are excluded.
- Have an active infection requiring systemic therapy.
- Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the best interest of the subject.
- Known psychiatric or substance abuse disorder that may affect compliance with test requirements.
- Female subjects who are pregnant or lactating, or who are expected to conceive during the planned trial period or up to 180 days after the last dose of study treatment, or male subjects whose spouse is preparing to become pregnant.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Ting Zhang, Prof., +8615157125533, zezht@zju.edu.cn
About this study
Official title: A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood
The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are:
How works well the Sintilimab was in the treatment group？ How safe the Sintilimab is？ Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence.
Researchers will compare invention group to control group to see if the Sintilimab works well.
Read the detailed description
The experimental group and the control group start treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle in the experimental group while placebo was given in the control group, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression.
- Being tested
- Sintilimab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
Sintilimab is administered intravenously on the first day of each cycle. 21 days per cycle.
PlaceboDrug
Also called 0.9% sodium chloride solution
Placebo is administered intravenously on the first day of each cycle. 21 days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | The experimental group started treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression. Receives: Drug: Sintilimab |
| Control arm | Placebo comparator | The control group started treatment within 1 month after the end of chemoradiotherapy, and placebo was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 3 years
1-year PFS
1-year progression-free survival
Measured: 1 year
Secondary outcomes (3)
OS
Overall Survival
Measured: 3 years
Safety and tolerability
All adverse events will be assessed by the investigator in accordance with NCI Common Terminology for Adverse Events (CTCAE) version 5.0.
Measured: 3 years
EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores
Assessment of quality of life of HNSCC
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start25 Jan 2024
- Primary completion25 Jan 2025 (estimated)
- Study completion5 Jan 2027 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240689
- Sponsor's protocol ID
- Y2023-0889
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 5 Feb 2024
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood
- ClinicalTrials.gov ID
- NCT06240689
- Acronym / sponsor ID
- Y2023-0889
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 5 Feb 2024 (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 goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are:
How works well the Sintilimab was in the treatment group？ How safe the Sintilimab is？ Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence.
Researchers will compare invention group to control group to see if the Sintilimab works well.
Detailed description
The experimental group and the control group start treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle in the experimental group while placebo was given in the control group, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Drug: SintilimabThe experimental group started treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression. |
| Control arm | Placebo comparator | Drug: PlaceboThe control group started treatment within 1 month after the end of chemoradiotherapy, and placebo was given intravenously on the first day of each cycle, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age ≥ 18 years old, ≤ 75 years old.
- Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
- Patients undergoing concurrent chemoradiotherapy
- ECOG performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (8 listed)
- Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.
- Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use of physiologic doses of corticosteroids may be approved.
- Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative therapy are excluded.
- Have an active infection requiring systemic therapy.
- Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the best interest of the subject.
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 |
|---|---|---|
| SintilimabAlso: IBI308Sintilimab is administered intravenously on the first day of each cycle. 21 days per cycle. | Drug | Interventional arm |
| PlaceboAlso: 0.9% sodium chloride solutionPlacebo is administered intravenously on the first day of each cycle. 21 days per cycle. | Drug | Control arm |
Primary outcome
PFS
Time frame: 3 years
progression-free survival
1-year PFS
Time frame: 1 year
1-year progression-free survival
3 secondary outcomes
OS
Time frame: 3 years
Safety and tolerability
Time frame: 3 years
EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Related trials for Locally Advanced Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Carcinoma, Squamous Cell
RecruitingPhase 1
A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang, prof. (+8615157125533, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 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 5 Feb 2024.