A prospective, single-arm, multicenter, Phase II clinical study of Apatolimab Tovolimab (QL1706) in combination with modified FLOT regimen (TFOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma
1. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol.
2. Age ≥18 years and ≤75 years at enrollment, regardless of gender.
3. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+).
4. No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma; previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease.
1. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Heart Association [NYHA] ≥Class II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, or hepatic, renal, or metabolic diseases.
2. Symptomatic brain and/or leptomeningeal metastases.
3. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
4. QT/QTc interval >450 ms for males, >470 ms for females.