Combining tislelizumab with chemotherapy for advanced head and neck tumors

A Prospective Single-center, Single-arm Clinical Study of the PD-1 Inhibitor Tislelizumab Combined With APF Sequential Surgery or Radical Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Head and Neck Tumors

This study is testing if combining a new immune treatment called tislelizumab with chemotherapy can help people with advanced head and neck tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone, tislelizumab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05758389 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of tislelizumab, an immune checkpoint inhibitor, combined with APF chemotherapy in patients with locally advanced head and neck tumors. Participants will receive this combination treatment followed by either sequential surgery or radical concurrent chemoradiotherapy. The study also seeks to explore the immune microenvironment genes related to treatment efficacy. The trial focuses on patients with specific histological types of head and neck tumors and measurable lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced head and neck tumors who have not previously received chemotherapy or radiotherapy.

Not a fit: Patients with early-stage tumors or those who have previously undergone chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with advanced head and neck tumors.

How similar studies have performed: Other studies have shown promise with similar combinations of immune checkpoint inhibitors and chemotherapy, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years old;
2. Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.;
3. Have at least one radiographically measurable lesion (RECIST 1.1 criteria);
4. The clinical stage is III-IVb (P16-) or II-III (P16+);
5. There are tumor samples that can detect gene expression;
6. ECOG score 0-1 points;
7. Have not received radiotherapy and chemotherapy or other anti-tumor drugs before;
8. The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L
9. The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT \< 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5xULN (for anticoagulation at a stable dose such as low molecular weight heparin or warfar.) LIN and INR can be screened within the expected therapeutic range of anticoagulants)
10. Subjects of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control);
11. Have signed informed consent;
12. Ability to follow study protocols and follow-up procedures.

Exclusion Criteria:

1. Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait;
2. Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.);
3. There is distant metastasis;
4. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood;
5. Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation);
6. Severe infection (CTC AE\>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging examination showed active lung Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics);
7. The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) \< 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible;
8. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA\<500IU/ml), and cured hepatitis C patients can be enrolled;
9. Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia;
10. Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment;
11. Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (\> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone \>10 mg/day is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time;
12. Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative;
13. Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences;
14. Those who may be allergic to the study drug;
15. Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors;
16. Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%);
17. Any uncertain factors affecting the safety or compliance of the subjects;
18. Contraindications to hormone use.

Where this trial is running

Nanjing, Jiangsu

• Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jing Yan

Conditions Head and Neck Tumors; Immune checkpoint inhibitors; Chemotherapy; Locally advanced head and neck tumors; Induction therapy