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Efficacy and safety of Paclitaxel (Albumin-bound) combined with Oxaliplatin and S-1 in preoperative adjuvant treatment of gastric cancer

Efficacy and safety of Paclitaxel (Albumin-bound) combined with Oxaliplatin and S-1 in preoperative adjuvant treatment of gastric cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032702
Enrollment
Unknown
Registered
2020-05-07
Start date
2021-12-01
Completion date
Unknown
Last updated
2021-12-06

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:Paclitaxel(Albumin-bound)

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with HER2 negative gastric cancer or cancer at the gastroesophageal junction confirmed histologically; 3. Ct3-4bn + MX in patients with operative local progression or potential resectable metastasis; 4. Tumor size can be measured according to the evaluation standard of solid tumor response (recist1.1 standard); 5. KFS score >= 70; 6. Bone marrow function: neutrophil >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, hemoglobin >= 90g / L; 7. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and alt <= 2.5 times the upper limit of normal value; total bilirubin <= 1.5 times the upper limit of normal value; 8. Patients who have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received radiotherapy or chemotherapy before; 2. Patients with squamous cell carcinoma of the gastroesophageal junction; 3. Patients with uncontrolled hypertension, congestive heart failure or myocardial infarction within six months; 4. Patients with any other malignancies in the past 5 years; 5. Patients with untreated central nervous system diseases or symptomatic central nervous system metastasis diseases; 6. Patients with upper gastrointestinal obstruction or abnormal physiological function, or with malabsorption syndrome, may affect S-1 absorption; 7. Pregnancy or lactation, and childbearing age patients who refuse to take appropriate contraceptive measures during the course of this trial; 8. Patients who need immunosuppressive therapy for organ transplantation; 9. Patients with uncontrolled severe infection or other serious concomitant diseases 10. Patients not suitable for this study were judged by the researchers.

Design outcomes

Primary

MeasureTime frame
pathology complete remission, pCR;objective remission rate, ORR;R0 resection rate;

Secondary

MeasureTime frame
progression-free survival, PFS;overall survival, OS;Adverse Events;

Countries

China

Contacts

Public ContactDa Mingxu

Department of Oncology, Gansu Provincial Hospital

hxdamingxu@hotmail.com+86 15095321201

Outcome results

None listed

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