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Advanced Gastric Cancer Adenocarcinoma of Esophagogastric JunctionPhase 2NCT03030937

Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA

A Phase 2 study testing Apatinib and Irinotecan in people with Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction, run by Fujian Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
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
74 participants
Where
1 siteChina
Study dates
1 Feb 2017to 30 Dec 2018
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：18~70years;
  • Subjects with Histologically or cytologically confirmed advanced gastric cancer or adenocarcinoma of esophagogastric junction ；
  • Subjects must have received no more than one lines treatment before participating,and have received no irinotecan or antiangiogenic（including apatinib）treatment previously; 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.
  • subjects with at least one measurable lesion as defined by RECIST (version 1.1);Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
  • Survival expectation≥ 3 months;
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  • The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound has healed before participating;
  • No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on );
  • Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
  • Hemoglobin (Hb)≥80g/L，
  • White blood count (WBC)≥3.5×109/L
  • Absolute neutrophil count (ANC)≥1.5×109/L，
  • Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
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  • Bilirubin ≤1.5×the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN), Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and GPT <5.0×(ULN)).
  • serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
  • Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
  • Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol

Who cannot join

  • Females are lactating or pregnant at Screening or Baseline
  • Subjects with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix)
  • Subjects with symptomatic brain metastases；
  • Subjects with uncontrolled blood pressure with medication (140/90 mmHg),
  • Subjects with coronary heart disease (CHD) above grade I, arrhythmia (including Prolongation of QTc interval : Male subjects > 450 ms, Females> 470 ms) or cardiac dysfunction;.
  • Subjects with gastrointestinal bleeding tendency,including the following: current of local active ulcerative lesions with fstool OB (+ +); history of melena or hematemesis within past 2 months ; current of fstool OB (+) with gastric primary tumor without surgical , investigator considerd ulcerative stomach cancer is associated with risks of gastrointestinal bleeding.
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  • Subjects with bleeding tendency ，defined as abnormal coagulation (INR>1.5×(ULN),APTT>1.5 ×(ULN));
  • Subjects with previous history of cardiovascular and cerebrovascular diseases ,those receiving thrombolytics or anticoagulants were excluded
  • Subjects with urine protein positive (defined as urine protein detection 2+ or above, or urine protein ≥ 1 g/24 hours );
  • Subjects with a variety of factors that affect oral medications (such as inability to swallow, persistent nausea and vomiting, chronic diarrhea and intestinal obstruction, and so on.);
  • Subject with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.

Trial locations and contacts

1 site in 1 country.

Jianwei Yang contact

008613805097959

swzcq62@163.com

Sha Huang contact

008613763820570

huangsha0210@163.com

China1 site

  • Jianwei Yang

    Fuzhou, Fujian, 350000

Other trials in China

About this study

Official title: A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in Subjects With Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction

The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.

Read the detailed description

Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis,so the prognosis is poor.Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of irinotecan was used as second line treatment,but limited survival benefit.Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.

Being tested
Apatinib, Irinotecan

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 NCT03030937
Study groupRoleWhat they receive
Irinotecan plus apatinibExperimentalIrinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ). Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
Receives: Drug: Apatinib; Drug: Irinotecan
IrinotecanActive comparatorIrinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.
Receives: Drug: Irinotecan

What is being measured

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

  1. Progression-Free Survival (PFS)

    Measured: 18 months

  2. Adverse Event（AE）

    NCI CTC 4.03

    Measured: 18 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Measured: 18 months

  2. Disease Control Rate (DCR)

    Measured: 18 months

  3. Overall Survival(OS)

    Measured: 18 months

  4. Quality of Life (QoL)

    Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].

    Measured: 18 months

Timeline

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

  1. First posted25 Jan 2017 (estimated)
  2. Study start1 Feb 2017 (estimated)
  3. Primary completion31 Jul 2018 (estimated)
  4. Study completion30 Dec 2018 (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
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030937
Sponsor's protocol ID
Arise-FJ-G201
Status last verified
Jan 2017
First submitted
15 Jan 2017
Last updated
25 Jan 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Irinotecan in people with Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction, run by Fujian Cancer Hospital 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 19 inclusion and 11 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 25 Jan 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 Jianwei Yang (008613805097959, swzcq62@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 (PFS) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT03030937.

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 25 Jan 2017.

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