Thyroid CancerPhase 2NCT03300765
Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer
A Phase 2 study testing Apatinib and Intensity modulated radiation therapy in people with Thyroid Cancer, run by Xiayun He, MD at 1 site in China.
Trial summary
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Apatinib and Intensity modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiayun He, MD,PhD, +86 13917564793
About this study
Official title: Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- Apatinib, Intensity modulated radiation therapy
- Keywords
- Thyroid Cancer, Apatinib, Intensity modulated radiation therapy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib will be used as induction therapy in experimental arm.
Intensity modulated radiation therapyRadiation
Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib with IMRT | Experimental | 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) Receives: Drug: Apatinib; Radiation: Intensity modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The time from date of randomization until date of first documented disease progression or death from any cause
Measured: 3-year
Secondary outcomes (5)
Short-term treatment response rate
Number of participants responded to the therapy according to RECIST 1.1
Measured: Three months after completion of the therapy
Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 3-year
Time to Response
Time to first response to the therapy according to RECIST 1.1
Measured: From the initial treatment to first response, up to 3 years
Duration of Response
Time from the first response to the therapy to disease progression
Measured: From first response to disease progression, up to 3 years
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
Incidence of acute and late toxicity
Measured: Time interval from start to 3 months after completion of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiayun He, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiayun He, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300765
- Sponsor's protocol ID
- HN-Shanghai
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study
- ClinicalTrials.gov ID
- NCT03300765
- Acronym / sponsor ID
- HN-Shanghai
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, Apatinib, Intensity modulated radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiayun He, MDUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib with IMRT | Experimental | Drug: Apatinib, Radiation: Intensity modulated radiation therapyParticipants 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibApatinib will be used as induction therapy in experimental arm. | Drug | Apatinib with IMRT |
| Intensity modulated radiation therapyIntensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy. | Radiation | Apatinib with IMRT |
Primary outcome
Progression Free Survival
Time frame: 3-year
The time from date of randomization until date of first documented disease progression or death from any cause
5 secondary outcomes
Short-term treatment response rate
Time frame: Three months after completion of the therapy
Overall survival
Time frame: 3-year
Time to Response
Time frame: From the initial treatment to first response, up to 3 years
Duration of Response
Time frame: From first response to disease progression, up to 3 years
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
Time frame: Time interval from start to 3 months after completion of the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Intensity modulated radiation therapy in people with Thyroid Cancer, run by Xiayun He, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiayun He, MD,PhD (+86 13917564793, hexiayun1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.