Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Aug 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced adenocarcinoma of the esophagogastric junction, which is a type of cancer affecting the area where the esophagus meets the stomach. The researchers want to see how effective and safe a combination of immunotherapy, using a PD-1 antibody, and chemoradiotherapy (a combination of chemotherapy and radiation) is for these patients. The trial is not yet recruiting participants but aims to help improve treatment options for this challenging condition.

To be eligible for this trial, participants should be between the ages of 18 and 75, have confirmed adenocarcinoma of the esophagogastric junction that is HER-2 negative, and have not received any prior cancer treatments. They must also have good overall health with specific organ function requirements and have at least one measurable tumor. Participants can expect to receive the new treatment regimen and will be monitored closely for its effects and any potential side effects. It's important for potential participants to know that they must be able to give their informed consent and comply with the study guidelines to take part in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
• • 2. Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
• • 3. No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
• • 4. Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
• • 5. At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
• • 6. Expected survival ≥6 months.
• • 7. Adequate organ function, Hemoglobin ≥90g/L; White blood cells ≥3.0×109/L; neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein \< 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein must be ≤ 1 g.
• • 8. Normal coagulation function, no active bleeding and thrombotic diseases: International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;
• • 9. Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the start of the study medication;
• • 10. Female patients should not be pregnant or breast feeding. Male should contraception.
• • 11. Able and willing to give informed consent to participate.
• • 12. Those who are expected to have good compliance.
• Exclusion Criteria:
• • 1. Existence of other active malignant tumors within 5 years or at the same time.
• • 2. Already received chemotherapy, radiation therapy, targeted or immunotherapy.
• • 3. Have any active autoimmune disease or history of autoimmune disease.
• • 4. Patients with congenital or acquired immunodeficiency.
• • 5. Use of immunosuppressive drugs within 14 days before the study start.
• • 6. Administer live attenuated vaccines within 4 weeks before the study start.
• • 7. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia.
• • 8. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.
• • 9. Suffering from active pulmonary tuberculosis.
• • 10. Complicated severe infection within 4 weeks before the the study start, or unexplained fever \>38.5°C during the screening period/before the study start.
• • 11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• • 13. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.
• • 15.Participators who had been recruited by other clinical trial within three months.