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Metastatic Gastric AdenocarcinomaPhase 2NCT03116555

Apatinib Plus Irinotecan as Second-line Treatment in AGC or EGJA

A Phase 2 study testing Apatinib and Irinotecan in people with Metastatic Gastric Adenocarcinoma, run by China Medical University, China at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, multicenter, single-group clinical study of Apatinib Plus Irinotecan as second-line treatment in locally advanced or metastatic gastric or gastroesophageal junctional adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Gastric Adenocarcinoma
What is being tested?
Apatinib and Irinotecan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
5 Apr 2017to Sep 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age：18-70，female or male.
  • Pathologically diagnosed local advanced or metastatic stomach or gastroesophageal junction with adenocarcinoma, at least one measurable objective tumor lesion by spiral CT examination（according to RECIST 1.1）.
  • First-line application of fluorouracil-based chemotherapy failed (treatment failure definition: toxic side effects can not tolerate the progress of the disease during treatment or recurrence after treatment); Note:(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant/neoadjuvant therapy was allowed; adjuvant/neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
  • UGT1A1*28(6/6) and *6(G/G) ,or UGT1A1*28(6/6) and *6(G/A),or UGT1A1*28(6/7) and *6(G/G).
  • ECOG performance status 0-1.
  • satisfactory main organ function，laboratory test must meet the following criteria: (1) blood routine examination standards to meet: A. HB≥90g/L; B. ANC≥1.5×109/L; C. PLT≥90×109/L; (2) biochemical tests to meet the following criteria: A. Total bilirubin≤1.5 times the upper limit of normal (ULN) B. ALT and AST≤2.5ULN; C. Serum Cr≤1ULN, endogenous creatinine clearance> 60ml/min (Cockcroft-Gault formula)
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  • The international normalized ratio (INR) ≤ 1.5 and some prothrombin time (PPT or APTT) ≤ 1.5ULN within 7 days before participating.
  • Expected survival≥3 months;
  • Signed informed consent (ICF) before admission;
  • Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, contraception should be used for surgical sterilization, or agreed to use the appropriate method 8 weeks after the trial and the last given test drug.

Who cannot join

  • Hypersensitivity to apatinib, irinotecan or excipients.
  • More than one chemotherapy regimen was treated after progression of gastric cancer (except for adjuvant/neoadjuvant chemotherapy with more than 24 weeks of clearance).
  • Prior exposure to irinotecan.
  • Prior exposure to irinotecan VEGFR inhibitors, such as apotinib, sorafenib, sunitinib.
  • Another primary tumor in patients, except for: systematically treatment non-melanoma skin cancer, effectively treatment cervical carcinoma in situ, or other effectively treatment tumors wtih no recurrence for more than 5 years.
  • Anti neoplastic cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other research drugs have been use within 4 weeks before participating.
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  • Uncontrolled hypertention with systolic blood pressure> 140 mmHg or diastolic blood pressure> 90 mmHg, grade I or more coronary heart disease, grade I arrhythmia (including QTc interval: male> 450 ms, female> 470 ms) and grade I cardiac insufficiency.
  • Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1g.
  • Any toxicity more than 1 grade(according to CTCAE) caused by previous treatment, except hair loss.
  • Occasional artery/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurred within 12 months before participation;
  • Intestinal obstruction occurred 4 weeks before participation.
  • Patients who underwent major surgery 4 weeks prior to initiation of treatment. The patient must be cured from any major surgery.
  • Patients who are considered to have a greater risk of medical care due to a serious, uncontrollable disease, non-metastatic systemic disease or active, uncontrollable infection. Some examples include, but not exclusively, uncontrolled ventricular arrhythmias, recent (3 months) myocardial infarction, uncontrollable epilepsy seizures, unstable spinal cord compression, superior vena cava syndrome, HRCT tips Bilateral interstitial lung disease or any mental illness that may obstruct informed consent.
  • Immunocompromised patients, for example, serological tests suggest that human immunodeficiency virus (HIV) is positive.
  • Pregnant or lactating women.
  • Have a variety of factors that affect oral medication (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
  • Patients with clear gastrointestinal bleeding tendencies. Including the following: there is black stool, hematemesis history in 2 months can not be grouped; For patient with fecal occult blood (+) and the primary tumor of the stomach tumor not surgical resected, if the center of the main investigators believe that there is possible occurrence of gastrointestinal bleeding,the patient can not be grouped.
  • Ascites or pleural effusion requiring clinical treatment of persistent.
  • A history or evidence of hereditary hemorrhagic physical or coagulopathy that increases the risk of bleeding.
  • With central nervous system metastasis with symptoms.
  • With Gilbert syndrome.
  • Participated in other drug clinical trials in four weeks.
  • Researchers believe that they are not suitable for inclusion.
  • Patients who had bone metastases and had undergone palliative radiotherapy (radiotherapy> 5% bone marrow area) within 4 weeks prior to the study.

Trial locations and contacts

1 site in 1 country.

YunPeng Liu, PhD contact

86-24-83282312

cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD contact

86-24-83282542

qu_xiujuan@hotmail.com

China1 site, 1 recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110010

    Yunpeng Liu, PhD, 86-24-83282312, cmuliuyunpeng@hotmail.com

    Xiujuan Qu, PhD, 86-24-83282542, qu_xiujuan@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter Clinical Study of Apatinib Plus Irinotecan as Second-line Treatment in Locally Advanced or Metastatic Gastric or Gastroesophageal Junctional Adenocarcinoma

This is a prospective, multicenter, single-group clinical study of Apatinib Plus Irinotecan as second-line treatment in locally advanced or metastatic gastric or gastroesophageal junctional adenocarcinoma.

Read the detailed description

This is a prospective, multicenter, single-group clinical study of Apatinib Plus Irinotecan as second-line treatment in locally advanced or metastatic gastric or gastroesophageal junctional adenocarcinoma. Interventions: Irinotecan: 180mg/m2, ivgtt,given on the first day; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day). Repeat the therapeutic schedule every 3 weeks till progressive disease or intolerable toxicities. Primary Outcome Measure: PFS. Secondary Outcome Measures: OS, ORR, DCR.

Being tested
Apatinib, Irinotecan
Keywords
Apatinib, Irinotecan, Second-line, Metastatic Gastric Adenocarcinoma

What participants receive

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

  • ApatinibDrug

    Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).

  • IrinotecanDrug

    Irinotecan was used as second line treatment with AGC

Study groups in NCT03116555
Study groupRoleWhat they receive
Irinotecan plus apatinibExperimentalIrinotecan: 180mg/m2, ivgtt,given on the first day; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day). Repeat the therapeutic schedule every 3 weeks till progressive disease or intolerable toxicities.
Receives: Drug: Apatinib; Drug: Irinotecan

What is being measured

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

  1. Progression Free Survival [PFS]

    Progression Free Survival

    Measured: 5-6 months

Secondary outcomes (3)

  1. Overall Survival [OS]

    Overall Survival

    Measured: 12-15 months

  2. Objective Response Rate [ORR]

    Objective Response Rate

    Measured: 12-15 months

  3. Disease Control Rate [DCR]

    Disease Control Rate

    Measured: 12-15 months

Timeline

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

  1. First posted17 Apr 2017
  2. Study start5 Apr 2017
  3. Primary completionMar 2020 (estimated)
  4. Study completionSep 2020 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03116555
Sponsor's protocol ID
CLOG0103
Status last verified
Nov 2019
First submitted
12 Apr 2017
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

    PubMed 18172173

  • Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.

    PubMed 18971936

  • Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

    PubMed 23918952

  • Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.

    PubMed 21742485

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Irinotecan in people with Metastatic Gastric Adenocarcinoma, run by China Medical University, China 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 10 inclusion and 24 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 13 Nov 2019. 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 YunPeng Liu, PhD (86-24-83282312, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival [PFS] (time frame: 5-6 months). 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 NCT03116555, which also lists 5 linked publications.

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 13 Nov 2019.

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