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Clinical Trials in China / NCT05505461
Starting soon Phase 2

Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma

NCT05505461 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Phase 2
Started
2023-01
Last updated
2022-08-17

Condition(s) studied

Adenocarcinoma of Esophagogastric Junction

Investigational drug(s) / intervention(s)

neoadjuvant Radiation plus SOX and PD-1 antibody

neoadjuvant Radiation plus SOX and PD-1 antibody: Patients will be given the perioperative treatment as below once recruited: First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles. The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable. SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery.

Study summary

The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05505461 on ClinicalTrials.gov ↗ ← All trials in China