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

NCT07161453 | Not Yet Recruiting Phase 4

• 2 other identifiers: NeoGC-04KY20250312
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastric / Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease

  The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years

Secondary Outcomes (2)

• Compare the differences in the OS rates between the two groups of subjects, OS (Overall Survival, which refers to the time from the start of postoperative adjuvant therapy until death due to any cause)

  The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years

• The Adverse Events of anti-PD1/PDL1 monoclonal antibody combined with chemotherapy versus chemotherapy in postoperative adjuvant treatment for gastric cancer/adenocarcinoma of the esophagogastric junction

  The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years

Study Arms (4)

SOX or XELOX with immunotherapy

EXPERIMENTAL

Drug: SOX plus PD-1 inhibitor

Immunotherapy

EXPERIMENTAL

Drug: PD-1 / PD-L1 monoclonal antibody

SOX or XELOX

ACTIVE COMPARATOR

Drug: SOX Chemotherapy

Tegafur-Ugotex or Capecitabine

ACTIVE COMPARATOR

Drug: Tegafur-Ugotex or Capecitabine

Interventions

SOX plus PD-1 inhibitor DRUG

SOX or XELOX plus PD-1 inhibitor

SOX or XELOX with immunotherapy

PD-1 / PD-L1 monoclonal antibody DRUG

PD-1/PD-L1 monoclonal antibody

Immunotherapy

SOX Chemotherapy DRUG

SOX or XELOX

SOX or XELOX

Tegafur-Ugotex or Capecitabine DRUG

Tegafur-Ugotex or Capecitabine

Tegafur-Ugotex or Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
• 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.

You may not qualify if:

• \) 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;

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Capecitabine

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08