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Adjuvant S-1 and inserted paclitaxel in patients with stage II-III gastric or gastroesophageal junction adenocarcinoma:a prospective, single arm, single center, phase II, exploratory IIT clinical study

Adjuvant S-1 and inserted paclitaxel in patients with stage II-III gastric or gastroesophageal junction adenocarcinoma:a prospective, single arm, single center, phase II, exploratory IIT clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095699
Enrollment
Unknown
Registered
2025-01-10
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Gastric or gastroesophageal junction adenocarcinoma

Interventions

Experimental group:Adjuvant chemotherapy regime ( S-1 and inserted paclitaxel)

Sponsors

The First Afliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily join this study and sign the informed consent form; 2. Age >= 18 and =12 months; 9. Normal function of major organs, that is, meeting the following criteria: (1) The criteria for routine blood examination shall meet: No blood transfusion and blood products within 14 days, not corrected with G-CSF and other hematopoietic stimulating factors) absolute neutrophil count >=1.5×10^9/L; platelets>=80×10^9/L; Hemoglobin > = 80 g/L (2) Biochemical examination shall meet the following standards: Total bilirubin 50 ml/min (male: endogenous creatinine clearance = ((140-age) × body weight)/(72× serum Cr); Female: endogenous creatinine clearance = ((140-age) × body weight) / (72× serum Cr) × 0.85; body weight unit: kg; Serum Cr unit: mg/mL); (3) Coagulation function must meet the following criteria: INR or PT<=1.5×ULN; APTT<=1.5×ULN Unless the subject is receiving anticoagulant therapy, as long as the PT or APTT is within the intended range of use of anticoagulant drugs; 10. Non-lactating or pregnant females, contraception during or 3 months after the end of treatment.

Exclusion criteria

Exclusion criteria: 1. Have squamous cell, neuroendocrine, or undifferentiated gastric cancer; 2. Previous or concurrent other malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and carcinoma in situ of the breast; 4. Gastroesophageal junction carcinoma involving EGJ and the tumor center is located at the proximal end of the stomach < = 2cm from EGJ; 5. Those who participate in other clinical experiments within 4 weeks; 6. Have a history of psychotropic drug abuse, alcohol abuse or drug abuse; 7. Known allergic or hypersensitivity to paclitaxel or any ingredient used within paclitaxel formulation, or other contraindications to treatment with taxane; 8. Pregnant or lactating women, or patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; 9. Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. If there is a serious illness (including psychiatric illness) that requires concomitant treatment, severe laboratory abnormalities, or other family or social factors.

Design outcomes

Primary

MeasureTime frame
Relapse free survival;

Secondary

MeasureTime frame
Overall Survival,OS;Safety of drug therapy;

Countries

China

Contacts

Public ContactTai Ma

The First Afliated Hospital of Anhui Medical University

910878760@qq.com+86 139 5695 9871

Outcome results

None listed

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