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Randomized, open, controlled phase II clinical study of apatinib piece (AiTan) combined the Sox scheme first-line treatment of advanced gastric cancer under the background of panoramic cancer gene detection.

Randomized, open, controlled phase II clinical study of apatinib piece (AiTan) combined the Sox scheme first-line treatment of advanced gastric cancer under the background of panoramic cancer gene detection.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17010609
Enrollment
Unknown
Registered
2017-02-10
Start date
2017-02-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

A gleam of gastric cancer

Interventions

treatment group:Apatinib Mesylate Tablets 250mg, Oxaliplatin 130mg/m2, Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/m2/d, 14 days
Control group:Oxaliplatin 130mg/m2, Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/m2/d, 14 days

Sponsors

Jiangsu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old, men or women; 2. advanced gastric cancer or gastroesophageal junction adenocarcinoma by pathological histology and/or cytology diagnosis and outside having stomach measurable lesions (10 mm or higher spiral CT scan, RECIST 1.1 standard); 3. The ECOG score 0 to 2 points; 4. The expected lifetime acuity in March; 5. Major organs function is normal, that meet the following criteria: (1) the blood routine examination standards must be in accordance with (14 days without blood transfusion and adjuvant therapies, unused and other hematopoietic stimulating factor (g-csf) correct): HB 90 g/L or higher; the ANC acuity 1.5 x 10^9/L; PLT acuity 80 x 10^9/L; (2) and biochemical examination must be in accordance with the following criteria: TBIL 45 ml/min (Cockcroft - Gault formula); 6. The doctor thinks treatment can bring benefit; 7. Patients can understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Confirmed the apatinib for the piece and/or its accessories allergies; 2. Pregnant or lactating women; 3. The apatinib for patients with contraindications(active bleeding, ulcer, bowel perforation, intestinal obstruction, hand within 30 days after operation, uncontrolled hypertension drugs, grade III - IV cardiac insufficiency, disabled) in patients with severe liver and kidney function; 4. Tumor tissue in patients with immunohistochemical or FISH testing positive for its Her - 2; 5. The doctor considered a person not eligible to be included in the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactShu Yongqian

Jiangsu province people's hospital

15298369207@163.com+86 13951017570

Outcome results

None listed

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