Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery (NCT06815705) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery
China23 participantsStarted 2025-03-20
Plain-language summary
Head and neck squamous cell carcinoma is one of the most common malignant tumors. At present, the standard treatment of head and neck squamous cell carcinoma recommended by the National Comprehensive Cancer Network(NCCN) treatment guideline in the United States and the Chinese Society of Clinical Oncology(CSCO) treatment guideline in China is a comprehensive treatment model based on surgery, supplemented by radiotherapy, chemotherapy, immunization and targeted therapy. Neck lymph dissection is one of the most important surgical procedures for the treatment of head and neck squamous cell carcinoma. The injury of surgery and postoperative adjuvant radiotherapy leads to inadequate drainage of lymphatic system, leading to head and neck lymphedema.
Vascularized lymph node transplantation is successfully used in the treatment of upper and lower limb lymphedema, but has not been reported in the treatment of head and neck lymphedema.
At present, neck lymph dissection is the standard surgical protocol for head and neck squamous cell carcinoma, and there is no clear evidence that neck lymph dissection can be avoided. The dorsal thoracic artery flap can be used to make the flap of chimeric axillary lymph node, and can also be used as one of the vascularized lymph transplantation donor areas for the treatment of lymphedema without increasing the risk of upper limb lymphedema in the donor area.
Therefore, the investigators propose: Can the function of the head and neck lymphatic system be reconstructed by transplanting normal lymph nodes from other parts of the body into the neck to form new lymphatic pathways at the same time of operation for head and neck squamous cell carcinoma? In our previous operation for head and neck squamous cell carcinoma, thoracic dorsal artery flap with partial axillary lymphoid tissue transplantation was used to repair head and neck defects. Retrospective analysis showed that the lymph node transplantation in the previous cases survived. Therefore, this project designed a prospective exploratory clinical study to clarify the activity and donor safety of cervical vascularized lymphatic transplantation, and further explore the effect of vascularized lymphatic tissue transplantation to rebuild the cervical lymphatic system in reducing the incidence of postoperative head and neck lymphedema, alleviating cervical fibrosis after radiotherapy and even improving the prognosis of patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. This study selected T2-3,N0-3,M0; Patients with T4a,N0-3,M0 head and neck squamous cell carcinoma (AJCC 8th) can be treated surgically with flap repair and no axillary lymphatic metastasis.
✓. No history of other malignant tumors 3.18-75 years old
✓. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109/L;
✓. Platelets ≥100×109/L in the past 14 days without blood transfusion;
✓. Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
✓. Total bilirubin ≤1.5× upper limit of normal (ULN);
✓. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);
✓. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥60 ml/min;
Exclusion criteria
✕
What they're measuring
1
Incidence of head and neck lymphedema within 2 years after surgery
Timeframe: At least 3 months to 2 years after surgery
2
severity of head and neck lymphedema within 2 years after surgery
Timeframe: At least 3 months to 2 years after surgery
Trial details
NCT IDNCT06815705
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. Diagnosis of other malignant tumors, or treatment of HNSCC did not start.
✕. Prior to treatment, an active autoimmune disease requiring systemic treatment (e.g. use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within the previous 2 years. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
✕. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
✕. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
✕. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);
✕. Pre-treatment HBV viral load \<1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout study treatment to avoid viral reactivation
✕. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
✕. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);