Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.

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

Details

• Lead Sponsor: Xiayun He, MD
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

• Aged ≥ 18 years old;

• Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);

• ECOG0-2;

• Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm^3; PLT ≥ 80,000/mm^3; HB≥90g/L;total bilirubin < 1.25ULN; AST/ALT < 2.5 ULN or < 5 ULN with metastasis; SCr ≤1ULN; CCR > 50ml/min;

• The survival period is expected to be greater than 3 months;

• Willing to accept adequate contraception for patients with childbearing potential.

Exclusion Criteria:

• Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;

• Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;

• Allergic to apainib;

• Uncontrolled high blood pressure and heart disease;

• Patients with gastrointestinal bleeding risk;

• Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN);

• Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity >1.0g);

• Pregnant or lactating women.