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Intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer, a phase II single-arm study

Intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17011812
Enrollment
Unknown
Registered
2017-06-30
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid cancer

Interventions

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 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; 2. Aged = 18 years old; 3. 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); 4. ECOG0-2; 5. 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 50ml/min; 6. The survival period is expected to be greater than 3 months; 7. Willing to accept adequate contraception for patients with childbearing potential.

Exclusion criteria

Exclusion criteria: 1. Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments; 2. Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib; 3. Allergic to apainib; 4. Uncontrolled high blood pressure and heart disease; 5. Patients with gastrointestinal bleeding risk; 6. Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN); 7. Uroprotein positive (Uroprotein=2+ or 24-hour urinary protein quantity >1.0g); 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Objective Response Rate;Disease Control Rate;Time to Response;Duration of Response;Overal Survival;Quality of Life;

Countries

China

Contacts

Public ContactXiayun He

Fudan University Shanghai Cancer Center

hexiayun1962@163.com+86 13917564793

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026