Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

Launched by SUZHOU ZELGEN BIOPHARMACEUTICALS CO.,LTD · Jul 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with differentiated thyroid cancer, which is a type of cancer that affects the thyroid gland. After surgery to remove most or all of the thyroid, participants will be divided into two groups to see which method works better for their recovery. One group will take thyroid hormone medication and receive special injections (called rhTSH) to prepare for treatment with a radioactive iodine pill. The other group will not take the hormone medication, allowing their thyroid-stimulating hormone (TSH) levels to rise before they take the radioactive iodine pill.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with a specific type of thyroid cancer. They should have had their surgery within the last year and be in generally good health. Participants can expect to receive close medical supervision and will need to follow a low iodine diet for two weeks before starting the treatment. This trial is actively recruiting participants, and it's important for potential volunteers to speak with their doctors to understand if they qualify and how they may benefit from being part of this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects voluntarily sign the informed consent form (ICF).
• • Age ≥ 18 years old, either male or female.
• • Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0.
• • Eastern Cooperative Oncology Group (ECOG) score of 0-2;
• • Expected life expectancy is greater than 12 weeks;
• • Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
• • Low iodine diet for two weeks prior to randomized.
• Exclusion Criteria:
• • patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
• • Pregnant or breast feeding women.
• • patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
• • Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
• • Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.