Anlotinib or Penpulimab in Combination With RAI for DTC

Thyroid Cancer Clinical Trial

Official title: The Efficacy and Safety of Anlotinib Hydrochloride or Penpulimab In Combination With RAI in Patients With Local Advanced or Metastatic Differentiated Thyroid Cancer: A Randomized, Open-label, Exploratory Clinical Trial

Status Recruiting

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of anlotinib in combination with I-131 in locally advanced/metastatic differentiated thyroid cancer. Anlotinib may stop the growth of tumor cells and improve iodine uptake.

Clinical Trial Description

Primary Outcome Measures:

objective response rate (ORR)

Secondary Outcome Measures：

1. Biochemical Response Rate (BRR) Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice

2. Disease Control Rate (DCR)

3. Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

4. Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging ;

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

• NCT number: NCT04952493
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Contact: Yansong Lin, MD
• Phone: +86-10-69155610
• Email: linys@pumch.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2021
• Completion date: July 20, 2024