Clinical study of Apatinib combination with SOX as First line treatment in patients with adenocarcinoma of the Stomach or Gastroesophageal Junction

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-17013262

Enrollment

Unknown

Registered

2017-11-06

Start date

2017-11-15

Completion date

Unknown

Last updated

2017-11-13

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

Conditions

gastric cancer

Interventions

Experimental group:Apatinib combined with SOX

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years male an female; 2. adenocarcinoma of the Stomach or Gastroesophageal Junction confirmed by pathology with measurable lesions(CT scan long diameter of tumor=10mm, as RECIST 1.1 standard requirements; 3. Patients with adenocarcinoma of the Stomach or Gastroesophageal Junction which has already Inoperable, locally advanced recurrence or metastasis; 4. ECOG 0-2; 5. The main organ function is normal, and meet the following standards: the standard of blood routine examination should be consistent (patients has not using blood transfusion in 14 days); HB=80g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; Biochemical tests: BIL=1.5ULN; ALT and AST=2.5×ULN, ALT and AST=5×ULN for liver metastasis patients; Serum Cr=1×ULN or creatinine clearance =50ml/min (Cockcroft-Gault); 6. Estimated survival time=3 mouths; 7. Surgery was performed more than 4 weeks ago and the wound was completely healed; 8. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib. For male, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib; 9. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. High blood pressure and failure to be reduced to normal range by antihypertensive drugs( Systolic pressure>140mmHg, Diastolic pressure >90mmHg), II class cardiac insufficiency; 2. Patients with severe primary diseases of heart, kidney and hematopoietic system 3.There are many factors affecting oral drug absorption(as unable to swallow, nausea and vomiting, chronic diarrhea and ?intestinal obstruction etc.) 4. Patients with high risk of gastrointestinal bleeding judged by researchers 5. Coagulopathy (INR>1.5×ULN APTT>1.5×ULN),with bleeding tendency; 6. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Progression Free Surivical;	—

Secondary

Measure	Time frame
Disease Control Rate;Overall Surivival;Objective Remission Rate;R0 Resection Rate;safety;	—

Countries

China

Contacts

Public ContactJuntian Wang

ahead-sxzl08@hotmail.com+86 13834501840

Outcome results

None listed

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