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CompletedNCT02426034Updated Jul 1, 2022

A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

A Phase 4 interventional study of ApatinibTablets in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,004
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.

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Conditions studied

  • Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

  • Advanced
  • Metastatic
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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

This study's enrollment of 2,004 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age: 18 to75 years old;
  2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
  3. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
  4. ECOG PS of 0-2;
  5. Major organ function has to meet the following criteria:

    For results of blood routine test (without blood transfusion within 14 days):

    HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L

    Biochemical tests results:

    Bilirubin \<1.25 times the upper limit of normal (ULN) ALT and AST \<2.5 × ULN; liver metastases, if any, the ALT and AST\<5 × ULN Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)

  6. An expected survival of ≥ 3 months;
  7. Patient received apatinib treatment regimen at investigators' discretion;
  8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
  9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction;
  2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  3. Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding;
  4. Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding;
  5. Presence of central nervous system metastases;
  6. Pregnant or lactating women;
  7. Other conditions regimented at investigators' discretion.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,004 participants (actual)

Study arms

  • Experimental
    Treatment group

    Apatinib Tablets

    Drug: ApatinibTablets

Interventions

  • DrugApatinibTablets

    Apatinib Tablets, recommended dose of 850mg

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What researchers measure

Primary outcomes

  1. Safety, which was assessed by recording the incidence and severity of adverse events

    Time frame: between first dose of apatinib and up to 30 days after the last dose of apatinib

Secondary outcomes

  1. Overall Survival

    Time frame: Event driven, an expected average of 34 weeks

  2. Progression Free Survival

    Time frame: An expected average of 12 weeks

  3. Objective Response Rate

    Time frame: An expected average of 12 weeks

  4. Disease Control Rate

    Time frame: An expected average of 12 weeks

  5. Quality of life, measured by the questionnaire of EORTC QLQ-C30

    Time frame: Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks

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Study locations

2 sites
  • Nanjin Military 81 Hosiptal
    Nanjing, Jiangsu, China
  • Fudan University cancer hospital
    Shanghai, Shanghai 200000, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02426034
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
May 15, 2015
Primary completion
May 29, 2020
Completion
Sep 3, 2020
Last update
Jul 1, 2022

Study contacts

Jin Li, MD
principal investigator · Fudan University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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