Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Aug 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced oral squamous cell carcinoma, a type of mouth cancer that can be removed by surgery. The study is testing whether giving two cycles of a medicine called adebrelimab (which helps the immune system fight cancer) combined with chemotherapy before surgery can work as well as the usual three cycles. The goal is to see if this shorter treatment can still shrink the tumor effectively, improve long-term survival, and cause fewer side effects or complications.

Adults aged 18 to 75 with certain stages of oral cancer that can be surgically removed might be eligible for this trial. Participants will receive two rounds of the immunotherapy plus chemotherapy before their surgery and will be closely monitored for how well the treatment works and any side effects. This study will look at how completely the cancer disappears after surgery and track patients’ health over the next several years to understand the benefits and safety of this treatment combination. If you or a loved one fit the criteria and are interested, this trial offers a chance to try a promising new treatment while helping researchers learn more about fighting this type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years old;
• • 2. According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;
• • 3. Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;
• • 4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;
• • 5. The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;
• • 6. Blood routine: White blood cell count (WBC) ≥ 3.0×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 100×109/L; Hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatments such as blood transfusion and increase in white blood cells within 7 days);
• • 7. Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); Albumin (ALB) ≥ 30 g/L;
• • 8. Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate (CrCl) ≥ 50 mL/min (using the Cockcroft/Gault formula); Urinary protein (UPRO) \< (++), or 24-hour urine protein quantity \< 1.0 gram;
• • 9. HPV status of oropharyngeal cancer was determined by p16 IHC. If more than 70% of tumor cells showed strong diffuse nuclear and cytoplasmic staining, the sample was considered p16 positive;
• • 10. Within the past 30 days, no other clinical trial projects were participated in;
• • 11. Patients who voluntarily participated in this project and signed the informed consent form.
• Exclusion Criteria:
• • 1. The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.
• • 2. The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.
• • 3. Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.
• • 4. The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.