An Exploratory Study to Evaluate the Efficacy of Anlotinib Hydrochloride Combined With Penpulimab in the Treatment of Radioiodine Refractory Differentiated Thyroid Cancer With First-line Resistance to Angiogenesis Inhibitors

Peking Union Medical College Hospital1 site in 1 country10 target enrollmentNovember 11, 2023

ConditionsLocally Advanced or Metastatic Radioiodine-refractory Differentiated Thyroid Carcinoma

InterventionsAnlotinib Hydrochloride Capsule and Penpulimab

DrugsAnlotinib Hydrochloride Capsule and Penpulimab

Overview

Phase: Not Applicable
Intervention: Anlotinib Hydrochloride Capsule and Penpulimab
Conditions: Locally Advanced or Metastatic Radioiodine-refractory Differentiated Thyroid Carcinoma
Sponsor: Peking Union Medical College Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Overall Response Rate (ORR)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to observe and explore the efficacy and safety of Anlotinib combined with penpulimab in the treatment of radioiodine refractory differentiated thyroid cancer with first-line resistance to angiogenesis inhibitors, and to summarize the treatment experience of population.

Registry

clinicaltrials.gov

Start Date

November 11, 2023

End Date

August 20, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients voluntarily joined the study, signed the informed consent;
•Patients were pathologically confirmed as locally advanced or metastatic differentiated thyroid cancer (DTC), having at least one measurable lesion (Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
•Patients≥18 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 6 months;
•Possessing imaging or clinical evidence of disease progression within the first 18 months of enrollment;
•Progression of at least one anti-vascular drug（no more than 2）；
•Tg and structural imaging examinations were performed at least twice before enrollment；
•Meet any of the following while meeting the above 3 items:（1）Lesions were not iodine-avid；（2） The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months. （3） Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
•Major organ functions meet the following criteria within 7 days prior to the treatment:
•Hemoglobin (Hb) ≥90g/L;
•Absolute Neutrophil Count (ANC) ≥1.5×109/L;

Exclusion Criteria

•Complicated diseases and history:
•Histologic subtypes of thyroid cancer other than the differentiated type (e.g., medullary carcinoma, lymphoma, or sarcoma) could not be enrolled; Patients currently have or had other malignancies within 5years. Cured localized tumors could be enrolled（e.g., Skin basal cell carcinoma）
•Subjects with any severe and/or uncontrolled heart disease, including:
•According to the criteria of New York Heart Association (NYHA) grade II or above cardiac insufficiency or echocardiography: LVEF (left ventricular ejection fraction) \<50%;
•Unstable angina
•A myocardial infarction had occurred within 1 year before the beginning of the treatment
•Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention
•QTc ≥450ms (male), QTc ≥470ms (female) (classified by New York heart association, NYHA);
•Other anti-tumor treatment (including but not limited to chemotherapy, radiotherapy, etc.). were received within 28 days before the beginning of the treatment; TSH suppression therapy was excluded;
•Patients who have previously used immune checkpoint inhibitors (including but not limited to nivolumab, pembrolizumab, toripalimab, sintilimab, etc.);