A Single-arm, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemotherapy Followed by Radiotherapy in the Perioperative Treatment of Gastroesophageal Junction Adenocarcinoma

22-OBU-BJ-GC-II-009

This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.

2022-08-25

2025-05-01

2028-05-01

Recruiting

Early phase I

68

Inclusion Criteria: 1. Male or female subjects aged from 18 to 80 years old; 2. Patients with pathologically confirmed gastroesophageal junction adenocarcinoma (Siewert II-III) 3. Resectable tumors with staging t3-4N0M0 or T1-4N+M0 confirmed by CT or MRI according to AJCC version 8 staging System; 4. Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); 5. No prior anti-tumor therapy, including surgery, chemotherapy, radiotherapy, targeted and immunotherapy; 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry; 7. Estimated life expectancy of more than 3 months; 8. Adequate haematological, hepatic and renal functions defined by the protocol; 9. Prior use of anti-tumor traditional Chinese medicine, proprietary Chinese medicine, immunomodulators (such as thymosin, interleukin, etc.) must be ≥2 weeks from the beginning of the study 10. Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for both male and female subjects if the risk of conception exists; 11. The subjects participated in the study voluntarily, fully understood and informed the study and signed the informed consent; Exclusion Criteria: 1. Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)； 2. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included; 3. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; 4. Active tuberculosis; 5. Prior organ transplantation, including allogeneic stem-cell transplantation； 6. Other protocol-defined inclusion/exclusion criteria could apply. 7. Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids; 8. Accination with live or live/attenuated viruses within 4 weeks of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines; 9. History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms; 10. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity; 11. Known history of allergy to the drug components of this regimen; 12. Presence of unresectable factors, including tumor, contraindications to surgery, or rejection of surgery; 13. Major surgical procedures were performed within 4 weeks prior to initial administration;

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2024-02-02