Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT06851260
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with thyroid cancer who require total thyroidectomy and bilateral central lymph node dissection.
* The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
* Age at the time of signing the informed consent form is between 18 and 80 years old, regardless of gender.
* The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1.
* Expected survival period is not less than 1 year.
* Male and female patients of childbearing age agreed to use reliable methods of contraception before entering the trial, during the research process, and up to 8 weeks after discontinuation of medication.
* Good organ function:
Hematology: Absolute neutrophil count (ANC) ≥ 1500/μ L; Platelets ≥ 100000/μ L; Hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L; Kidney: Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using the Cock Gault formula); Liver: For subjects with total bilirubin levels ≤ 1.5 × ULN or for subjects with total bilirubin levels\>1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the subject still meets the inclusion criteria; Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects undergoing anticoagulant therapy as long as PT or aPTT is within the prescribed range of use of the anticoagulant drug; Willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan.
Exclusion Criteria:
* There are locally advanced unresectable or metastatic diseases.
* History of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment.
* Known history of active tuberculosis.
* Known to have active infections that require systematic treatment.
* Any subjects with known or suspected autoimmune diseases or immune deficiencies.
* Uncontrolled active hepatitis B (defined as hepatitis B B virus surface antigen \[HBsAg\] test result in screening period is positive and HBV-DNA test value is higher than the upper limit of normal value in the laboratory department of the research center.
* Subjects with HBV-DNA levels\<500 IU/mL within 28 days prior to randomization, who have received local standard antiviral treatment for at least 14 days and are willing to continue receiving antiviral treatment during the study period, are eligible for enrollment; Subjects with active hepatitis C (defined as those who test positive for hepatitis C virus surface antibody \[HCsAb\] and HCV-RNA during the screening period).
* Known human immunodeficiency virus (HIV) infection (known to be HIV antibody positive).
* Administer a live vaccine within 30 days prior to the first dose.
* Have ≥ grade 2 peripheral neuropathy.
* Has experienced severe allergic reactions to other monoclonal antibodies.
* Known to have serious or uncontrolled underlying diseases; Including but not limited to hemodynamic instability cardiovascular events, symptomatic cerebrovascular events, and Child Pugh A or higher liver cirrhosis that occur within 6 months.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06851260
Study Brief:
Protocol Section:
NCT06851260