Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.

Eligibility criteria

Qualifiers

Sign on the informed consent form (ICF)

Histologically confirmed esophagogastric junction Adenocarcinoma (AEG, Type Siewert I/II/ III), the stage is locally advanced cT1b-2N+ or T3-4Nany that the investigator judges it to be resectable (1. CT or MRI assessment shows no invasion of adjacent organs or tissues, 2. No peritoneal metastasis occurs, 3. There are surgical indications) (Note: If bone lesions are suspected, a bone scan is required; if peritoneal carcinomatosis is suspected, laparoscopy is required to confirm; if T3-T4 subjects have diffuse tissue types, diagnostic laparoscopy is also required))

No previous systematic treatment

At least one measurable lesion according to RECIST 1.1.

Disqualifiers

Histologically confirmed Squamous cell carcinoma or mixed type.

Distant metastasis: If peritoneal cancer or ascites is suspected by imaging, histological or cytological confirmation such as laparoscopic exploration is required.

Medical history and complications: 1.Having contraindications to surgical resection of esophagogastric junction cancer 2.Having any known active autoimmune diseases 3.Having any complications that require systemic treatment with glucocorticoids such as prednisone (>10 mg/day) or have used immunosuppressive drugs within 14 days before the first dose

Having received tumor vaccines or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within 1 month before the first dose 4.Having participated in other clinical trials or have received drug interventions from other clinical trials within 4 weeks before the first dose 5.Having other malignant tumors that need treatment 6.Having a history of severe cardiovascular disease 7.Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation

Trial design

Treatments tested in this trial

  • Adebrelimab (anti-PD-L1) + XELOX

Treatment groups

26 Participants
are divided into 1 treatment group

Sponsors and collaborators