NCT04952493

Anlotinib or Penpulimab in Combination With RAI for DTC

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.
DRUG	Sodium Iodide I 131	RAI treatment may shrink the tumor
DRUG	Penpulimab	Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC.

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-07-20
• Completion: 2024-07-20
• First posted: 2021-07-07
• Last updated: 2022-01-28

Locations

1 site across 1 country: China