Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help patients with head and neck squamous cell carcinoma (a type of cancer) by reconstructing the lymphatic system during surgery. When lymph nodes are removed during surgery, it can lead to swelling (lymphedema) in the neck. The trial will test if transplanting healthy lymph nodes from another part of the body into the neck during surgery can create new pathways for lymph fluid to flow and reduce swelling after surgery.

To be eligible for this trial, participants should be between 18 and 75 years old, have specific types of head and neck squamous cell carcinoma, and not have any other active cancers or certain health conditions that could complicate the treatment. Throughout the study, participants can expect careful monitoring and follow-up to assess how well the lymph node transplant works. This research could potentially improve recovery and quality of life for patients undergoing surgery for this type of cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. No history of other malignant tumors 3.18-75 years old
• 4. Baseline check is normal:
• • 1. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109/L;
• • 2. Platelets ≥100×109/L in the past 14 days without blood transfusion;
• • 3. Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
• • 4. Total bilirubin ≤1.5× upper limit of normal (ULN);
• • 5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);
• • 6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥60 ml/min;
• • 7. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
• • 8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• • 9. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);
• • 10. For female subjects of reproductive age, a urine or serum pregnancy test should be taken and the result is negative within 3 days prior to the first treatment (day
• • 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;
• • 11. If there is a risk of conception, all subjects (male or female) should use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last treatment (or 180 days after the last chemotherapy drug administration).
• • 12. No axillary lymph node metastasis.
• Exclusion Criteria:
• • 1. Diagnosis of other malignant tumors, or treatment of HNSCC did not start.
• • 2. 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;
• • 3. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• • 4. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• • 5. 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);
• Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• • 1. Pre-treatment HBV viral load \<1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout study treatment to avoid viral reactivation
• • 2. 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
• • 6. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
• • 7. Pregnant or lactating women;
• 8. The presence of any serious or uncontrolled systemic disease, such as:
• • 1. The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;
• • 2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
• • 3. Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;
• • 4. Poor blood pressure control (systolic \> 140 mmHg, diastolic \> 90 mmHg);
• • 5. There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to treatment, or there is currently clinically active interstitial lung disease;
• • 6. Active pulmonary tuberculosis;
• • 7. There is an active or uncontrolled infection that requires systemic treatment;
• • 8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
• • 9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• • 10. Poor diabetes control (fasting blood glucose (FBG) \> 10mmol/L);
• • 11. Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \> 1.0 g;
• • 12. Patients with mental disorders who cannot cooperate with treatment;
• • 9. Axillary lymphatic metastasis
• • 10. Medical history or evidence of disease that may interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers other potential risks unsuitable for participation in the study.