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

NCT ID: NCT03300765

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-05-01

Brief Summary

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

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apatinib with IMRT

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)

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Apatinib will be used as induction therapy in experimental arm.

Intensity modulated radiation therapy

Intervention Type RADIATION

Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.

Interventions

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Apatinib

Apatinib will be used as induction therapy in experimental arm.

Intervention Type DRUG

Intensity modulated radiation therapy

Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiayun He, MD

OTHER

Sponsor Role lead

Responsible Party

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Xiayun He, MD

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiayun He, MD,PhD

Role: CONTACT

[email protected]
+86 13917564793

Fen Xue, MD

Role: CONTACT

[email protected]
+86 18505123563

Facility Contacts

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Xiayun He, MD,PhD

Role: primary

+86 13917564793

Other Identifiers

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HN-Shanghai

Identifier Type: -

Identifier Source: org_study_id