Skip to content

Effectiveness and safety of S-1 combined Apatinib and TACE regimen for conversion therapy of unresectable local advanced gastric cancer: a single-arm, single-center, prospective clinical trial

Effectiveness and safety of S-1 combined Apatinib and TACE regimen for conversion therapy of unresectable local advanced gastric cancer: a single-arm, single-center, prospective clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022426
Enrollment
Unknown
Registered
2019-04-10
Start date
2019-03-30
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

gastric cancer

Interventions

Case series:S1+Apatinib Mesylate+TACE

Sponsors

People's Hospital of Tongling City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~80 years, males or females; 2. Definitely diagnosed gastric adenocarcinoma or adenocarcinoma of esophagogastric junction through Pathology or Cytology; 3. Imaging evaluation or exploration during planned radical surgery for gastric cancer reveal that radical resection (D2 + R0) can not be performed,followed at least one of the criteria below: a. Tumors invade duodenum, pancreas, mesenteric root and/or hepatoduodenal ligament,radical surgery can not be performed. b. Para-aortic lymph node enlargement(> 1cm). c. Multiple perigastric lymph nodes enlargement or main perigastric blood vessels surrounded by fused lymph nodes, D2 lymph node dissection can not be performed. 4. ECOG(Eastern Cooperative Oncology Group) 0~2; 5. Expected lifetime acuity =3 months; 6. Adequate organ functions defined as indicated below: (1) Adequate bone marrow function, defined as:a. HB=90 g/Lb. ANC=1.5×10^9/Lc. PLT=80×10^9/L (2) Adequate liver function, defined as: TBIL45ml/min using Cockcroft-Gault formula or Cr=1.25×ULN; 7. Females of childbearing potential must not be lactating or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 7 days before the first dose of study drug. 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. 8. Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating females; 2. History of hypertension, systolic blood pressure> 140 mmHg and/or diastolic blood pressure> 90 mmHg after medical treatment;history of coronary heart disease and/or arrhythmia greater than New York Heart Association (NYHA) Class I and/or cardiac insufficiency = Class II; 3. Coagulant function abnormality (INR > 1.5 and/or prothrombin time (PT) > ULN + 4 seconds and/or APTT > 1.5 ULN), bleed-ing tendency undergoing thrombolytic and anticoagulant therapy; 4. Pulmonary hemorrhage (> CTCAE 2) occurred within 4 weeks before administration, and other bleeding (> CTCAE 3) occurred within 4 weeks before administration; 5. History of gastric surgery; 6. Distant metastases (cM1) exclude inclusion criterias; 7. Any medical or other condition that in the opinion of the investigator would preclude the subjects participation in a clinical study.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;D2 lymph node dissection rat;

Secondary

MeasureTime frame
overall survival;tumor regression grade;

Countries

China

Contacts

Public ContactGuihe Wang

Department of Gastrointestinal Surgery, People's hospital of Tongling City

17297293@qq.com+8613965239876

Outcome results

None listed

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