Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiaoning Cancer Hospital & Institute

About this trial

This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology

Eligibility criteria

Qualifiers

Age ≥ 18 years old, gender not restricted;

Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;

HER2 overexpression or amplification results are negative;

Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;

Disqualifiers

1) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;

Trial design

Treatments tested in this trial

  • SOX plus PD-1 inhibitor
  • PD-1 / PD-L1 monoclonal antibody
  • SOX Chemotherapy
  • Tegafur-Ugotex or Capecitabine

Treatment groups

500 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Liaoning Cancer Hospital & Institute

Lead sponsor