Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

Korábbi kezelés

• Receipt of any antitumor therapy prior to surgery.
• History of or concurrent malignancies other than gastric cancer.
• Concurrent participation in another clinical trial.
• Contraindications to chemotherapy, radiotherapy, or surgery.
• Ongoing treatment with sorivudine or related analogs.

Más betegség

• Presence of psychiatric disorders, brain metastases, or leptomeningeal metastases.
• Uncontrolled or severe comorbid conditions or active infections.
• Decompensated dysfunction of major organs (e.g., cardiac, pulmonary, hepatic, or renal failure).
• Active hepatitis B or hepatitis C virus infection.
• Chronic intestinal diseases or short bowel syndrome.
• Known hypersensitivity to capecitabine or any of its excipients.

Egyéb

• Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
• Grade ≥2 peripheral neuropathy (per NCI-CTCAE).
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Deemed unsuitable for participation in this clinical trial by the investigator.

• Histologically confirmed gastric cancer with clinical staging determined by endoscopic ultrasound and contrast-enhanced CT or MRI as cT3N2/N3M0, cT4aN+M0, or cT4bNanyM0.
• Good general condition, with Eastern Cooperative Oncology Group (ECOG) performance status <2 and no contraindications to surgery.
• Ambulatory male or female patients aged 18 to 75 years.
• Sufficient physical fitness and organ function to tolerate major abdominal surgery.
• Baseline laboratory parameters meeting the following criteria: WBC > 4.0 × 10⁹/L, ANC > 1.5 × 10⁹/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10⁹/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, and serum creatinine ≤ 1.0 × ULN.
• No prior or concurrent diagnosis of other malignancies.
• Willing and able to comply with study protocol requirements during the trial period.
• Provided written informed consent prior to screening, with full awareness of the right to withdraw from the study at any time without consequence.
• Estimated life expectancy of at least 3 months.