Clinical trial · Interventional
Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer
Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study
NCT03300765CI-TRIAL-00029763unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib with IMRT
- description
- 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)
- interventionNames
- Drug: Apatinib
- Radiation: Intensity modulated radiation therapy
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 3-year
- description
- The time from date of randomization until date of first documented disease progression or death from any cause
Secondary outcomes (5)
- measure
- Short-term treatment response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.