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Clinical Trials in China / NCT06016413
Starting soon Phase 2

Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck

NCT06016413 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2023-09-01
Last updated
2023-08-29

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Nab paclitaxel →Carboplatin →adelbelimumab

Nab paclitaxel: All patients received nab-paclitaxel 260 mg/m2 intravenously on day 1 of each 3-week cycle for 3 cycles.

Carboplatin: All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.

adelbelimumab: All patients received carboplatin AUC=5 intravenously on day 1 of each 3-week cycle for 3 cycles.

Study summary

This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18-75 years old 2. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors 3. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis 4. According to RECIST 1.1, there is at least one measurable tumor lesion 5. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 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 treatment such as blood transfusion and leukocytosis within 7 days). 7. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients without liver metastasis ≤ 2.5 times the upper limit of the reference value (ULN); albumin (ALB) ≥ 30 g /L. 8. Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50mL/min (using the Cockcroft/Galter formula); urine protein (UPRO) \< (++), or 24 Hourly urine protein \< 1.0 g. 9. Determination of HPV status in oropharyngeal cancers using p16 IHC. A sample was considered p16 positive if \>70% of tumor cells exhibited intense diffuse nuclear and cytoplasmic staining 10. Have not participated in other clinical trial projects in the past 30 days; 11. Patients who voluntarily participate in the project and sign the informed consent. Exclusion Criteria: 1. The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation 2. The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy 3. The entire clinical research process cannot be completed due to personal, social and economic reasons 4. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital Guangzhou Guangdong

More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06016413 on ClinicalTrials.gov ↗ ← All trials in China