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Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer

ConditionGastric / Gastroesophageal Junction Adenocarcinoma
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 chemotherapy combined with or without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer

Eligibility criteria

This trial does not accept healthy volunteers

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

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;

Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency;

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;

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SOX plus PD-1 inhibitor

    Drug

    SOX or XELOX plus PD-1 inhibitor

  • SOX Chemotherapy

    Drug

    SOX or XELOX

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: SOX or XELOX with immunotherapyExperimental treatment 1 intervention
Group B: SOX or XELOXActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liaoning Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: