Status:
UNKNOWN
Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer
Lead Sponsor:
Xiayun He, MD
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03300765
Start Date
July 1 2017
End Date
May 1 2020
Last Update
October 3 2017
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032