Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC

NCT06978829 | Recruiting Phase 2

• 1 other identifier: 202552
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.

Conditions

LA HNSCC

Keywords

Tislelizumab; Cetuximab; LA HNSCC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) after conversion treatment. Based on RECIST 1.1.

  6 months

Secondary Outcomes (5)

• R0 resection rate

  6 months

• Major Pathological Response Rate (MPR)

  6 months

• Progression free survival (PFS)

  up to 5 years

• Overall Survival (OS)

  up to 5 years

• Adverse Event rate

  up to 2 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Conversion therapy stage：TP+Cetuximab+Tislelizumab. Radical therapy stage: Those assessed as operable receive curative surgery, while those assessed as inoperable undergo radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year.

Drug: TP + Cetuximab + Tislelizumab

Interventions

TP + Cetuximab + Tislelizumab DRUG

Conversion therapy stage: TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W. Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total. Patients who have completed conversion therapy undergo efficacy evaluation. Radical therapy stage: Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen. Evaluated as inoperable: Receive radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;
• Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;
• No prior treatment for head and neck squamous cell carcinoma;
• No prior treatment with cetuximab or PD-(L)1 inhibitors;
• At least one measurable lesion according to RECIST v1.1;
• No gender restriction, age ≥18;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Expected survival period ≥ 3 months;
• Organ function levels meet the following criteria:
• Blood routine: Hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥90×10\^9/L;
• 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;
• Cardiac function: Left ventricular ejection fraction \>50% as shown by echocardiography.
• 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.

You may not qualify if:

• Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
• 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;
• 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;
• 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;
• Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU/mL) or active hepatitis C (positive hepatitis C antibody) patients;
• Patients with active tuberculosis (with exposure history or positive tuberculosis test; accompanied by clinical and/or imaging manifestations);
• Patients who have undergone major surgery within 4 weeks before the first dose or whose wounds have not fully healed;
• Patients with a clear tendency to bleed;
• Patients with severe complications such as pyloric obstruction, upper gastrointestinal bleeding, gastrointestinal perforation, obstructive jaundice, severe malnutrition, etc.;
• Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;
• 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;
• History of interstitial lung disease, non-infectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.;
• Patients with active brain metastasis;
• Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer);
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Interventions

Cetuximab; tislelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Juan Li

CONTACT

86+13883272120; lljuan1019@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-02

Locations

CN (1)