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Nasopharyngeal CarcinomaPhase 2NCT03612219

Adjuvant Treatment of Apatinib in Nasopharyngeal Carcinoma

A Phase 2 study testing Apatinib mesylate tablet, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is to evaluate the efficacy and safety of apatinib for adjuvant treatment of High-risk metastasis of nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including progression-free survival (PFS),evaluation of drug safety.,and overall survival (OS),distant metastasisfree survival… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Apatinib mesylate tablet, Intensity-modulated radiation therapy (IMRT) and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
6 sitesChina
Study dates
1 Jul 2018to 28 Jul 2021
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) Tumor staged as T4 or N2-3 or lymph node>3cm and M0(according to the 8th AJCC edition).
  • Adequate hematological function: hemoglobin >80 g/L, neutrophil count > 1.5×10^9/L, platelet count 80×10^9/L.
  • Adequate liver function (serum transminase ≤ 2.5 times higher than upper limit),adequate renal function (creatinine clearance ≥ 60 mL/min).
  • Karnofsky performance status (KPS) score of at least 70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must give signed informed consent.

Who cannot join

  • Other or mixed pathological type.
  • age > 70 years.
  • Severe heart, liver and kidney damage.
  • History of other malignancy.
  • Prior chemotherapy or radiation of the primary tumor.
  • History of psychiatric disorders.
Show all 18Show fewer
  • Positive urine protein.
  • A healed wound for long time or incomplete fracture.
  • Before treatment,MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
  • Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg.
  • Any unstable angina pectoris;with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
  • Medical history of arteriovenous thrombosis event within the past year, such as cerebral vascular accident (including transient ischemic attack) and deep venous thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged that the patient had recovered, these patients should be except) and pulmonary embolism.
  • Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
  • Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
  • For females:patients should be surgical sterilization or postmenopausal patients, or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment; serum or urine pregnancy test must be negative, and must be non lactating period within 7 days before study; for males: patients should be treated with surgical sterilization or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment.
  • Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction.
  • Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Trial locations and contacts

6 sites in 1 country.

Wei Jiang, Ph.D. contact

+86-773-2882906

weijiang@glmc.edu.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • People's Hospital of Baise

    Baise City, Guangxi

    Enrolling by invitation

  • Guangxi Naxishan Hospital

    Guilin, Guangxi

    Enrolling by invitation

  • Guilin Medical University

    Guilin, Guangxi

    Wei Jiang, Ph.D, +8613788561863, weijiang@glmc.edu.cn

    Recruiting

  • People's Hospital of Laibin

    Laibin, Guangxi

    Enrolling by invitation

  • People's Hospital of Lingshan

    Linshan, Guangxi

    Enrolling by invitation

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi

    Enrolling by invitation

Other trials in China

About this study

Official title: A Multicenter, Phase II Clinical Study of Adjuvant Apatinib After IMRT With Concurrent Chemotherapy Versus IMRT With Concurrent Chemotherapy in High-risk Metastasis of Nasopharyngeal Carcinoma

The study is to evaluate the efficacy and safety of apatinib for adjuvant treatment of High-risk metastasis of nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including progression-free survival (PFS),evaluation of drug safety.,and overall survival (OS),distant metastasisfree survival (DMFS),locoregional relapse-free survival (LRRFS),and quality of life score (QoL).

Read the detailed description

PRIMARY OBJECTIVES:

Ⅰ.To determine if adjuvant apatinib after IMRT with concurrent chemotherapy is better to only obeservation after IMRT with concurrent chemotherapy for progression-free survival in High-risk metastasis of nasopharyngeal carcinoma.

SECONDARY OBJECTIVES:

Ⅰ.To explore the adjuvant medication regimen of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.

Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients.

OUTLINE:

Patients are randomized to one of the two treatment arms.

ARM 1: treat with apatinib(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles) for adjuvant treatment of local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.

ARM 2:only obeservation after IMRT with concurrent chemotherapy. IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

Concurrent chemotherapy:Cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.

After completion of study therapy, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years.

Being tested
Apatinib mesylate tablet, Intensity-modulated radiation therapy (IMRT), Cisplatin
Keywords
Nasopharyngeal Carcinoma, Apatinib, Adjuvant treatment, Progression-free survival
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apatinib mesylate tabletDrug

    Also called No.

    Adjuvant treatment by apatinib mesylate tablet to local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.the dose of apatinib mesylate tablet was 250 mg,orally,qd,28 days for an observation period,six cycles.

  • Intensity-modulated radiation therapy (IMRT)Radiation

    Also called No.

    Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.

  • CisplatinDrug

    Also called No.

    Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.

Study groups in NCT03612219
Study groupRoleWhat they receive
IMRT with CC+Adjuvant ApatinibExperimentalTreat with Apatinib mesylate tablet for adjuvant treatment(the dose was 250 mg,orally,qd,28 days for an observation period,Six cycles)of local advanced nasopharyngeal carcinoma after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).
Receives: Drug: Apatinib mesylate tablet; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin
IMRT with CCActive comparatorOnly obeservation after Intensity-modulated radiation therapy (IMRT) with concurrent chemotherapy(cisplatin).
Receives: Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The time from the first day of therapy to locoregional relapse, distant relapse or tumor-related death

    Measured: 3 years

Secondary outcomes (3)

  1. Overall survival

    The time from the first day of therapy to death or last follow-up

    Measured: 3 years

  2. Locoregional relapse-free survival

    The time from the first day of treatment to the time of first locoregional relapse

    Measured: 3 years

  3. Distant metastasis-free survival

    The time from the first day of treatment to the time of first distant metastasis

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start1 Jul 2018
  3. Primary completion28 Jul 2021 (estimated)
  4. Study completion28 Jul 2021 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612219
Sponsor's protocol ID
GLMU-04
Status last verified
Jul 2018
First submitted
27 Jul 2018
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib mesylate tablet, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 6 sites 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 5 inclusion and 18 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 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 Wei Jiang, Ph.D. (+86-773-2882906, weijiang@glmc.edu.cn), 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 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03612219.

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 2 Aug 2018.

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