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
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.
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 →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.
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)
Exclusion Criteria:
Apatinib Tablets
Drug: ApatinibTablets
Apatinib Tablets, recommended dose of 850mg
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
Overall Survival
Time frame: Event driven, an expected average of 34 weeks
Progression Free Survival
Time frame: An expected average of 12 weeks
Objective Response Rate
Time frame: An expected average of 12 weeks
Disease Control Rate
Time frame: An expected average of 12 weeks
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
Plan to share: Undecided
No publications or documents are linked to this record.
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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Jiangsu HengRui Medicine Co., Ltd.