Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma

Korábbi kezelés

• Already received chemotherapy, radiation therapy, targeted or immunotherapy.
• Use of immunosuppressive drugs within 14 days before the study start.
• Administer live attenuated vaccines within 4 weeks before the study start.
• Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.
• 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.

Más betegség

• Existence of other active malignant tumors within 5 years or at the same time.
• Have any active autoimmune disease or history of autoimmune disease.
• 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.
• Suffering from active pulmonary tuberculosis.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• 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.

Egyéb

• Patients with congenital or acquired immunodeficiency.

• Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
• Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
• No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
• Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
• At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
• Expected survival ≥6 months.
• 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.
• 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;
• 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;
• Female patients should not be pregnant or breast feeding. Male should contraception.
• Able and willing to give informed consent to participate.
• Those who are expected to have good compliance.