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Traflouridine tepiridine (TAS-102) combined with oxaliplatin in the perioperative treatment of elderly patients with gastric / gastroesophageal junction adenocarcinoma: an open, single arm, single center clinical study

Traflouridine tepiridine (TAS-102) combined with oxaliplatin in the perioperative treatment of elderly patients with gastric / gastroesophageal junction adenocarcinoma: an open, single arm, single center clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091149
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-10-30
Completion date
Unknown
Last updated
2024-10-28

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:oxaliplatin+TAS-102

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. age = 70, male or female; 2. ECoG score 0-2; 3. gastric adenocarcinoma / gastroesophageal junction adenocarcinoma diagnosed by histology or pathology; 4. TNM stage is t1-2n+m0 or t3-4nanym0; 5. there were evaluable lesions through imaging examination within 21 days before enrollment; 6. if the main organ function is normal, it meets the following criteria: (1) Blood routine examination criteria should meet: ANC = 1.5 × 109/L; PLT = 90 × 109/L; Hb= 90g/l; (2) Biochemical examination should meet the following criteria: TBIL = upper limit of normal (ULN); ALT and Ast = 1.5 times the upper limit of normal value (ULN); Alkaline phosphatase = 2.5 times the upper limit of normal (ULN); Bun and Cr = 1.5 × ULN and creatinine clearance = 50 ml/min (cockcroftgault formula); (3) Coagulation test standards should meet: international normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN, activated partial thromboplastin time (APTT) = 1.5x ULN; (4) Echocardiography and echocardiography: left ventricular ejection fraction (LVEF = 55%); (5) The QT interval (QTCF) corrected by fridericia method in electrocardiogram was <470 MS in women. Male < 450ms; 7. sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. previously treated with TAS-102; 2. Previously received anti-tumor treatment or radiation therapy, excluding cured malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma; 3. receiving anti-tumor therapy in other clinical trials at the same time; 4. have undergone major surgical procedures within 4 weeks before enrollment, or the patient has not yet fully recovered from such surgical procedures; 5. serious heart disease or discomfort, including but not limited to the following diseases: --Confirmed history of heart failure or systolic dysfunction (LVEF 180 mmHg and / or diastolic blood pressure > 100 mmHg); 6. other situations that the researcher judged as inappropriate for inclusion;

Design outcomes

Primary

MeasureTime frame
pathologic complete response;

Secondary

MeasureTime frame
safety;R0 resection rate;

Countries

China

Contacts

Public ContactLiu Tao

The First Affiliated Hospital of Zhengzhou University

It8361@163.com+86 135 9266 8787

Outcome results

None listed

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