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

Phase 2

• Conditions: Thyroid Cancer
• Interventions: Drug: Apatinib; Radiation: Intensity modulated radiation therapy

• Registration Number: NCT03300765
• Lead Sponsor: Xiayun He, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-28
• Last Update Submitted: 2017-09-28
• Study First Posted: 2017-10-03
• Last Update Posted: 2017-10-03
• Primary Completion: 2019-07-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib with IMRT	Intensity modulated radiation therapy	Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)
Apatinib with IMRT	Apatinib	Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	3-year	The time from date of randomization until date of first documented disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
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
Short-term treatment response rate	Three months after completion of the therapy	Number of participants responded to the therapy according to RECIST 1.1
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China