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

Last updated: September 28, 2017
Sponsor: Xiayun He, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Cancer

Treatment

N/A

Clinical Study ID

NCT03300765
HN-Shanghai
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 beforethe enrollment in the trial;

  • Aged ≥ 18 years old;

  • Pathologically confirmed inoperable or iodine refractory thyroid cancer, orpostoperative residual disease detected by imaging studies, or progression diseasewithin 12 months before enrollment. (all with measurable disease ≥10mm according toRECIST 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 ULNor < 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

Exclusion Criteria:

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

  • Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitiniband 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.

Study Design

Total Participants: 20
Study Start date:
July 01, 2017
Estimated Completion Date:
May 01, 2020

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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