Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma

NCT05994365 | Recruiting

• 1 other identifier: A LOT-DTC-1
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 3

Brief Summary

The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).

  Baseline up to 3 years.

• Progression-free Survival (PFS)

  From the first dose to the date of objective disease progression or death, whichever occurs first.

  Baseline up to 3 years.

Secondary Outcomes (4)

• Disease-control Rate (DCR)

  Baseline up to 3 years.

• Duration of Response (DOR)

  Baseline up to 3 years.

• Overall Survival (OS)

  Baseline up to 3 years.

• Adverse event rate

  Baseline up to 3 years.

Study Arms (2)

Anlotinib group

Anlotinib hydrochloride capsules: 12 mg once daily for 2 weeks, followed by a discontinuation of 1 week (21 days as a cycle)

Drug: Anlotinib Hydrochloride Capsule

Observation group

Observation: prospectively and retrospectively collect data of patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors.

Interventions

Anlotinib Hydrochloride Capsule DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation.

Anlotinib group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Patients

You may qualify if:

• Patients voluntarily participate in this study, sign the informed consent form and had good compliance;
• Aged 18 \~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; more than 6 months of expected survival ;
• Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer, radiographically documented disease progression within 18 months of absence of radioactive iodine (RAI) therapy;
• Meet any of the following:
• Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH) elevation (≥ 30 mIU/L). The definition of no iodine uptake:
• no iodine uptake initially;
• exist of iodine uptake initially while lost subsequently;
• partially uptake;
• progression disease despite iodine uptake.
• The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months.
• Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
• Major organ functions meet the following criteria within 7 days prior to treatment:
• Blood routine test criteria (14 days without blood transfusion):
• Hemoglobin (HB) ≥ 85 g/L;

You may not qualify if:

• Comorbidities and medical history:
• A history of or concurrent with other malignancies within the past 3 years. Patients were eligible if they had disease-free survival (DFS) for 5 consecutive years in other malignancies treated by single surgery; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of study treatment;
• Subjects with any severe and/or uncontrolled illness, including:
• Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including Corrected QT Interval (QTc)≥450ms(male), QTc≥ 470ms(female)) and ≥ grade 2 congestive heart failure (NYHA classification);
• Severe active or uncontrolled infection (≥ grade 2 infection according to Common Terminology Criteria for Adverse Events (CTCAE) );
• Renal failure requiring hemodialysis or peritoneal dialysis;
• Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study, or patients who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators.
• patients with previous treatment with anlotinib hydrochloride capsules or similar vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or sorafenib, etc.;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (3)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100007, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300122, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Ming Gao, PhD

CONTACT

+ 86 18622221110; gaoming68@aliyun.com

Yansong Lin, PhD

CONTACT

+86 13671116837; linys@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

CN (3)