Combining Cetuximab, Tislelizumab, and Chemotherapy for Advanced Head and Neck Cancer

Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study

This study is testing a new combination of treatments for patients with advanced head and neck cancer to see if it helps them get better and possibly have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Drugs / interventions: cetuximab, chemotherapy, immunotherapy, Tislelizumab
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06978829 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness and safety of a treatment regimen combining Cetuximab, Tislelizumab, and chemotherapy for patients with unresectable locally advanced head and neck squamous cell carcinoma (LA HNSCC). The study will enroll 42 patients who will receive three cycles of treatment, followed by an assessment of their response. Patients deemed resectable may undergo surgery, while those unsuitable for surgery will receive radical radiotherapy and maintenance treatment. The goal is to determine the surgical conversion rate and overall efficacy of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable locally advanced head and neck squamous cell carcinoma who have not received prior treatment.

Not a fit: Patients with prior treatments for head and neck squamous cell carcinoma or those with significant comorbidities 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 cancer by increasing the chances of surgical resection and overall survival.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating advanced cancers, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;
2. Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;
3. No prior treatment for head and neck squamous cell carcinoma;
4. No prior treatment with cetuximab or PD-(L)1 inhibitors;
5. At least one measurable lesion according to RECIST v1.1;
6. No gender restriction, age ≥18;
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
8. Expected survival period ≥ 3 months;
9. Organ function levels meet the following criteria:

   1. Blood routine: Hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥90×10\^9/L;
   2. Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g/L;
   3. Cardiac function: Left ventricular ejection fraction \>50% as shown by echocardiography.
10. Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.

Exclusion Criteria:

1. Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
2. Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;
3. Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation \>470 ms), and grade I cardiac insufficiency;
4. History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
5. Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU/mL) or active hepatitis C (positive hepatitis C antibody) patients;
6. Patients with active tuberculosis (with exposure history or positive tuberculosis test; accompanied by clinical and/or imaging manifestations);
7. Patients who have undergone major surgery within 4 weeks before the first dose or whose wounds have not fully healed;
8. Patients with a clear tendency to bleed;
9. Patients with severe complications such as pyloric obstruction, upper gastrointestinal bleeding, gastrointestinal perforation, obstructive jaundice, severe malnutrition, etc.;
10. Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;
11. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor is highly likely to invade important blood vessels during treatment, leading to fatal massive bleeding;
12. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.;
13. Patients with active brain metastasis;
14. Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer);
15. Pregnant or breastfeeding women;
16. Patients with severe concomitant diseases that endanger patient safety or affect the completion of the study, as judged by the investigator, and those whom the investigator considers unsuitable for inclusion.

Where this trial is running

Chongqing, Chongqing Municipality

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Juan Li

Conditions LA HNSCC; Tislelizumab; Cetuximab