Gastroesophageal/Gastric adenocarcinoma
Conditions
Interventions
Control Group:Radical Gastrectomy Combined with Perioperative Systemic Therapy
Study Group:Radical Gastrectomy Combined with Neoadjuvant Therapy and ctDNA-MRD-guided Postoperative Adjuvant Therapy Strategy
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1: Be able to provide a written informed consent form (ICF), and understand, agree to, and comply with the study requirements and assessment schedule. 2: Male or female aged 18 to 79 years. 3: Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), with clinical TNM staging (per the 8th edition of the AJCC/UICC Clinical TNM Staging for Gastric Cancer) as clinical Stage cIII to cIVa, and the primary gastric cancer lesion assessed to be amenable to curative resection. 4: ECOG PS = 1.5 × 10^?/Lb) Platelet Count (PLT) >= 75 × 10^?/Lc) Hemoglobin (Hb) >= 80 g/Ld) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 60 mL/min/1.73m²f) Serum Albumin (ALB) >= 30 g/L;g) For subjects not receiving anticoagulant therapy: International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN; for subjects receiving anticoagulant therapy: PT value must be within the expected therapeutic range for the anticoagulant used. 7: No antitumor treatment for the tumor involved in the current study has been administered prior to the initiation of neoadjuvant treatment.
Exclusion criteria
Exclusion criteria: 1: Subjects for whom investigators consider that there are obvious contraindications to (neo)adjuvant treatment or who cannot tolerate (neo)adjuvant treatment. 2: Females of childbearing potential who have not undergone surgical sterilization or do not use adequate contraceptive measures, pregnant or lactating females, and males who plan to impregnate their partners in the near term. 3: Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding, diabetes mellitus, and others. 4: Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis (TB), human immunodeficiency virus (HIV) infection, and others. 5: History of previous malignant tumors or other malignant tumors currently present, except for basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic/cervical/breast carcinoma in situ, and other such tumors that have been completely resected with no recurrence for at least 5 years. 6: Other circumstances that investigators deem inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;ctDNA Clearance Rate;Pathological Complete Response (pCR) Rate;The time point of ctDNA conversion from negative to positive and the time difference from the time point of radiological diagnosis of tumor recurrence; | — |
Countries
China
Contacts
Public ContactXuefei Wang
Zhongshan Hospital, Fudan University
Outcome results
None listed