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NCT Number: NCT07161453

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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;

Treatment and study plan

SOX plus PD-1 inhibitor

Drug

SOX or XELOX plus PD-1 inhibitor

PD-1 / PD-L1 monoclonal antibody

Drug

PD-1/PD-L1 monoclonal antibody

SOX Chemotherapy

Drug

SOX or XELOX

Tegafur-Ugotex or Capecitabine

Drug

Tegafur-Ugotex or Capecitabine

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

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

Secondary outcomes

  1. 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)

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

  2. 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

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

Sponsors and collaborators

Lead sponsor

Liaoning Cancer Hospital & Institute

Other

Registry information

Official study title

A Multicenter, Prospective, Real-world Study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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