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New treatment option for LA HNSCC
Official title Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC
ClinicalTrials.gov ID: NCT06978829
What this study is testing
What is TP + Cetuximab + Tislelizumab?
TP + Cetuximab + Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for la hnscc.
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 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.
- 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 and older
You may be able to join 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...
- 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;
You likely can't join 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...
- Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure \>140 mmHg, diastolic...
- History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these...
- 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);
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing 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.