Skip to content

Single-arm, prospective and exploratory clinical study for the efficacy of Apatinib combined with Paclitaxel, Tegafur, Gimeracil and Oteracil Potassium chemotherapy regimen in the treatment of gastric hepatoid adenocarcinoma

Single-arm, prospective and exploratory clinical study for the efficacy of Apatinib combined with Paclitaxel, Tegafur, Gimeracil and Oteracil Potassium chemotherapy regimen in the treatment of gastric hepatoid adenocarcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022213
Enrollment
Unknown
Registered
2019-03-30
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric hepatoid adenocarcinoma

Interventions

Case Series:Apatinib, Paclitaxel, Tegafur, Gimeracil and Oteracil Potassium

Sponsors

Harbin Medical University Cancer Hospital-gastroenterology Department
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Histopathological diagnosed as hepatoid adenocarcinoma of the stomach; 3. According to RECIST v1.1 guidelines, at least 1 lesion, with the longest diameter 10mm, was suitable for repeated and accurate measurement; 4. ECOG PS: 0-2 points; 5. Expected survival 3 months; 6. The main organs had good functions, that is, the relevant examination indexes within 14 days before enrollment met the following requirements: (1) blood routine examination, which should meet (no blood transfusion within 14 days) : A. Hemoglobin (HB) 90g/L; B. Neutrophil (ANC) 1.5x10^9/L; C. Platelet (PLT) 80x10^9/L (2) biochemical examination shall meet the following standards: A. Total bilirubin (BIL) <1.5 times normal upper limit (ULN) B. ALT or AST<5 ULN; C. Serum Cr 1 ULN, endogenous creatinine clearance 50ml/min (Cockcroft-Gault formula) 7. Patients voluntarily participated in the study and signed the informed consent (ICF); 8. Women of child-bearing age must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use an appropriate method of contraception during observation and within 8 weeks after the last administration of the test drug; For men, surgical sterilization should be performed, or an appropriate method of contraception should be agreed during observation and within 8 weeks of the last administration of the experimental drug.

Exclusion criteria

Exclusion criteria: 1. Heart disease in any of the following situations: (1) Recent history of heart disease (within 6 months): acute coronary syndrome, Acute heart failure (NYHA class of ? or ?), significant ventricular arrhythmias (persistent ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation); (2) When a magnitude of ? NYHA classification or ? level in patients with heart failure; (3) The patient had severe block and permanent pacemaker failure (second - and third-degree atrioventricular block, sinus block); (4) There was an unexplained fainting within 3 months; (5) Severe uncontrolled hypertension, or symptomatic hypertension, as determined by the researchers. 2. Multiple factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 3. Abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN), with bleeding tendency; 4. Any history of allergy or hypersensitivity to any of the study drugs or their excipients; 5. Pregnant or lactating women; Special attention: patients with risk of gastrointestinal bleeding were not included in the group, including the following situations: (1) active peptic ulcer lesions and fecal occult blood (++); (2) have a history of black stool or hematemesis within 3 months.

Design outcomes

Primary

MeasureTime frame
FPS;

Secondary

MeasureTime frame
ORR;DCR;OS;

Countries

China

Contacts

Public ContactYuxian Bai
bai_yuxian@126.com+86 0451-86298689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026