Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC (NCT06978829) | Clinical Trial Compass
RecruitingPhase 2
Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC
China42 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 6 months
Trial details
NCT IDNCT06978829
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
. 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;