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New treatment option for Head and Neck Cancer
Official title Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
ClinicalTrials.gov ID: NCT06494943
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed informed consent and willing to complete the study as per the protocol;
- Age ≥ 18 years and ≤ 75 years;
- Histologically confirmed head and neck squamous cell carcinoma, including primary sites in the oropharynx, oral cavity, larynx, and hypopharynx;
- Resectable locally advanced head and neck squamous cell carcinoma (AJCC 8th edition: Stage III-IVB);
- At least one measurable lesion before treatment, meeting the RECIST 1.1 criteria for "measurable disease";
You likely can't join if
- Participants will be excluded from the study if they meet any of the following criteria:
- History of or concurrent other malignancies (excluding those that have been cured with a cancer-free survival period of more than 5 years, such as...
- Receipt of any of the following treatments:
- Any investigational drug within 4 weeks prior to the first use of the study drug;
- Concurrent participation in another clinical study, unless it is an observational (non-treatment) clinical study;
- Systemic treatment with corticosteroids (daily dose \>10 mg prednisone equivalent) or other immunosuppressive drugs within 2 weeks before the first...
See the full eligibility criteria
Who can join
- Signed informed consent and willing to complete the study as per the protocol;
- Age ≥ 18 years and ≤ 75 years;
- Histologically confirmed head and neck squamous cell carcinoma, including primary sites in the oropharynx, oral cavity, larynx, and hypopharynx;
- Resectable locally advanced head and neck squamous cell carcinoma (AJCC 8th edition: Stage III-IVB);
- At least one measurable lesion before treatment, meeting the RECIST 1.1 criteria for "measurable disease";
- Expected survival \> 3 months;
- ECOG performance status 0-1;
- Adequate organ function meeting the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
- Platelet count ≥ 100 × 10\^9/L;
- Hemoglobin ≥ 9 g/dL;
- Serum albumin ≥ 2.8 g/dL;
- Total bilirubin ≤ 1.5 × ULN, ALT, AST, and/or ALP ≤ 3 × ULN;
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL/min (Cockcroft-Gault, see Appendix III);
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulants such as low-molecular-weight heparin or warfarin with INR within the...
- Patients with HBV infection and inactive/asymptomatic HBV carriers, or those with chronic or active HBV, may be enrolled if HBV DNA \< 500 IU/mL (or 2500 copies/mL) at screening. Patients with positive HCV antibodies...
- Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before treatment and use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms)...
- Non-sterilized male participants must agree to use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose of...
What rules you out
- Participants will be excluded from the study if they meet any of the following criteria:
- History of or concurrent other malignancies (excluding those that have been cured with a cancer-free survival period of more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and...
- Receipt of any of the following treatments:
- Any investigational drug within 4 weeks prior to the first use of the study drug;
- Concurrent participation in another clinical study, unless it is an observational (non-treatment) clinical study;
- Systemic treatment with corticosteroids (daily dose \>10 mg prednisone equivalent) or other immunosuppressive drugs within 2 weeks before the first use of the study drug, except for corticosteroids used for local...
- Anti-tumor vaccination or live vaccination within 4 weeks prior to the first administration of the study drug (for COVID-19 vaccination, the interval between vaccination and treatment should be more than 2 weeks);
- Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
- Uncontrolled cardiac clinical symptoms or diseases, such as:
- Heart failure of NYHA class II or higher;
- Unstable angina;
- Myocardial infarction within 1 year;
- Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infections (CTCAE \> Grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complications of infections. Baseline chest imaging...
- Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not...
- History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
- History of interstitial lung disease (excluding radiation pneumonitis that did not require steroid treatment) or non-infectious pneumonia;
- Active pulmonary tuberculosis infection identified by history or CT scan, or a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or a history of active pulmonary tuberculosis...
- Participants with active hepatitis B (HBV DNA ≥500 IU/mL or 2500 copies/mL) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection by the assay);
- Known history of psychiatric drug abuse, alcoholism, or drug addiction;
- Pregnant or breastfeeding women;
- Other factors deemed by the investigator that could lead to forced early termination of the study, such as severe concomitant disease (including mental illness) requiring combined treatment, severely abnormal laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.