Thyroid Cancer
Conditions
Keywords
Thyroid Cancer, Apatinib, Intensity modulated radiation therapy
Brief summary
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
Interventions
DRUGApatinib
Apatinib will be used as induction therapy in experimental arm.
RADIATIONIntensity modulated radiation therapy
Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.
Sponsors
Xiayun He, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 3-year | The time from date of randomization until date of first documented disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term treatment response rate | Three months after completion of the therapy | Number of participants responded to the therapy according to RECIST 1.1 |
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
| Time to Response | From the initial treatment to first response, up to 3 years | Time to first response to the therapy according to RECIST 1.1 |
| Duration of Response | From first response to disease progression, up to 3 years | Time from the first response to the therapy to disease progression |
| Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 | Time interval from start to 3 months after completion of the therapy | Incidence of acute and late toxicity |
Countries
China
Contacts
Primary ContactXiayun He, MD,PhD
Backup ContactFen Xue, MD
Outcome results
None listed