NCT07137858Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Head and neck cancer
- NCT number
- NCT07137858
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 15 Aug 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.
Other
- 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.
- Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.
Who the study is looking for
- Age between 18 and 75 years old;
- 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;
- Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;
- The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;
- 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);
- 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;
- 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;
- 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;
- Within the past 30 days, no other clinical trial projects were participated in;
- Patients who voluntarily participated in this project and signed the informed consent form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.