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

Dalian University of Technology

Status and phase: Not yet enrolling; Phase 4

Conditions: Gastric / Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: PD-1 / PD-L1 monoclonal antibody; Drug: SOX plus PD-1 inhibitor; Drug: SOX Chemotherapy; Drug: Tegafur-Ugotex or Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT07161453

KY20250312 (Other Identifier)

NeoGC-04

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old, gender not restricted;
2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
3. HER2 overexpression or amplification results are negative;
4. Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
5. Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
6. After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

SOX or XELOX with immunotherapy

Experimental group

Treatment:

Drug: SOX plus PD-1 inhibitor

Immunotherapy

Experimental group

Treatment:

Drug: PD-1 / PD-L1 monoclonal antibody

SOX or XELOX

Active Comparator group

Treatment:

Drug: SOX Chemotherapy

Tegafur-Ugotex or Capecitabine

Active Comparator group

Treatment:

Drug: Tegafur-Ugotex or Capecitabine