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An Open-label, Randomized Controlled Clinical Study: Neoadjuvant Chemotherapy using Paclitaxel Liposomes in Combination With Tegafur Verus Oxaliplatin Combination With Tegafur in Local Advanced Gastric Cancer

An Open-label, Randomized Controlled Clinical Study: Neoadjuvant Chemotherapy using Paclitaxel Liposomes in Combination With Tegafur Verus Oxaliplatin Combination With Tegafur in Local Advanced Gastric Cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012201
Enrollment
Unknown
Registered
2017-07-31
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Gastric Cancer

Interventions

Paclitaxel Liposomes plusTegafur group:Paclitaxel Liposomes +Tegafur
Oxaliplatin plus Tegafur group:Oxaliplatin + Tegafur

Sponsors

the First affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old male and female; 2. ECOG (Eastern Cooperative Oncology Group) 0-1; 3. Definitely diagnosed gastric adenocarcinoma through Pathology or Cytology; 4. Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS); 5. The Expected lifetime =12 weeks; 6. Adequate bone marrow function, defined as: White blood count (WBC)=3.0×10^9/L; Absolute neutrophil count (ANC) =2.0×10^9/L; Platelet count (PLT)=100×10^9/L; Hemoglobin (Hb)=100g/L; 7. Adequate liver function, defined as: Bilirubin =1.5×the upper limit of normal (ULN); Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) =2.5×(ULN), Alkaline phosphatase(ALP)=5×(ULN); 8. Kidney function defined as: serum creatinine=1.0×(ULN), or endogenous creatinine clearance rate =50 mL/min; 9. Without the history of anti-tumor therapy including Radiotherapy, chemotherapy, targeted therapy, Immunotherapy; 10. Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. In the past (5 years) or at the same time with other uncured malignant tumours except for cured skin basal cell carcinoma and cervical carcinoma in situ;With non-removable distant metastasis; 2. With central nervous system metastasis; 3. aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the upper normal limit(ULT); and Alkaline phosphatase(ALP)> 5×(ULN); 4. Previously treated with radiotherapy (pain to palliative radiotherapy and evaluate the lesion was not in the radiation field except); 5. serious uncontrolled co-morbid conditions; 6. Pregnant and lactating women; 7. Patients with reproductive possibilities do not wish or do not take effective contraceptive measures; 8. Simultaneous participation in another study or participation in another study within 4 weeks of commencement of this study; 9. Drug allergy to experimental medicine; 10. The researchers don't think that is suitable for inclusion; 11. Organ allografts requiring immunosuppressive therapy.

Design outcomes

Primary

MeasureTime frame
DCR;

Secondary

MeasureTime frame
pCR;ORR;Total resection rate;DFS;Safety;

Countries

China

Contacts

Public ContactZhigang Peng

the First affiliated Hospital of Guangxi Medical University

Drpzg001@163.com+86 0771-5353121

Outcome results

None listed

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