Combining immunotherapy with chemotherapy for esophagogastric junction cancer treatment

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

This study is testing if combining a new immunotherapy drug with standard chemotherapy can help people with operable esophagogastric junction cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: Adbrelimab, prednisone, Adebrelimab, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06482788 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of the immunotherapy drug Adebrelimab, a PD-L1 inhibitor, in combination with standard chemotherapy (XELOX) for patients with resectable esophagogastric junction adenocarcinoma. Participants will undergo a 28-day screening period to assess eligibility, including central verification of clinical stage. Eligible patients will receive perioperative treatment with Adebrelimab and XELOX, with special attention given to tumor location and PD-L1 status. The study aims to determine the feasibility of this combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed resectable esophagogastric junction adenocarcinoma who meet specific clinical and organ function criteria.

Not a fit: Patients with previous systemic treatment or those with unresectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with esophagogastric junction adenocarcinoma by enhancing the effectiveness of chemotherapy through immunotherapy.

How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with chemotherapy have shown promising results in other cancer types.

Eligibility criteria

Inclusion Criteria:

* 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.
* ECOG PS: 0-1
* The functions of important organs meet the following requirements：Absolute neutrophil count ≥ 1.5 × 109/L； Platelet ≥ 100 × 109/L； Hemoglobin ≥ 90g / l; ALT and AST ≤ 2.5 times ULN; TBIL ≤ 1.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min; INR ≤ 1.5, APTT ≤ 1.5 times ULN; No obvious abnormality on electrocardiogram.
* Male subjects and women of childbearing age must take contraceptive measures from the first dose to the last 3 months of use of the study drug.

Exclusion Criteria:

* 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
* Severe allergic reaction to drugs (Adbrelimab, Capecitabine, Oxaliplatin).
* The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive.
* According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Esophagogastric Junction Adenocarcinoma