Status:
NOT_YET_RECRUITING
Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 carcin...
Detailed Description
According to the latest data from the International Agency for Research on Cancer, the new incidence of head and neck cancer in the world in 2022 will be among the top ten new incidences of cancer in ...
Eligibility Criteria
Inclusion
- Age between 18-75 years old
- 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
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
- According to RECIST 1.1, there is at least one measurable tumor lesion
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 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 treatment such as blood transfusion and leukocytosis within 7 days).
- 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.
- 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.
- 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
- Have not participated in other clinical trial projects in the past 30 days;
- Patients who voluntarily participate in the project and sign the informed consent.
Exclusion
- The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
- The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
- The entire clinical research process cannot be completed due to personal, social and economic reasons
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06016413
Start Date
September 1 2023
End Date
December 1 2026
Last Update
August 29 2023
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120