Study on the Treatment of Differentiated Thyroid Carcinoma With Anlotinib

• Status: Recruiting
• Trial end date: 2022-12-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of anlotinib in patients with locally advanced or metastatic differentiated thyroid cancer resistant to iodine therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yansong Lin

Criteria

Inclusion Criteria:

• Histopathology confirmed the locally advanced or metastatic differentiated thyroid cancer.At least have a measurable lesions (RECIST1.1)

• Age:18-70 years old ECOG PS: 0-1. Life expectancy of at least 6 months

• (1) The tumor cannot be completely removed, and the residual thyroid tissue is wide and is not suitable for further iodine treatment. (2) The lesion is free from iodine. (3) Cumulative RAI (radioactive iodine) dose ≥ 600 mci or 22 Gbq. (4) Radiology examination confirmed that disease progression in 18 months after RAI treatment.

• Pregnancy test (serum or urine) must be carried out within 7 days, and the test results must be negative. The inclusion patient should take appropriate contraceptive measures during the study and till 6 months after the last administration.

Exclusion Criteria:

• Patients who have received external radiotherapy or iodine-131 therapy in recent 3 months, or plan to receive other systemic anti-tumor therapy or anti-tumor therapy with traditional Chinese medicine during the study period.

• Patients with other malignant tumors within 5 years or currently. Except primary cervical cancer, non-melanoma skin cancer and superficial bladder tumor.

• The toxicity of CTCAE (4.0) above grade 1 was not alleviated, excluding patients with neurotoxicity (≤ grade 2) and alopecia caused by oxaliplatin.

• With factors affecting oral administration (such as swallow, chronic diarrhea, etc.).

• Patients with pleural effusion or ascites causing respiratory syndrome (CTCAE2 level above).

• Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.

• Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.

• Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.