An exploratory clinical study to evaluate the safety, tolerability, and efficacy of low-dose radiotherapy (LDRT) and stereotactic radiotherapy (SBRT) combined with CAPEOX and tirellizumab in first-line treatment of HER2-negative advanced gastric cancer

Phase 1

• Conditions: Gastric adenocarcinoma

• Registration Number: ChiCTR2400089068
• Lead Sponsor: West China Hospital of Sichuan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Voluntary participation in clinical trials; Patients fully understand and know the study and sign the informed consent; Willing to follow and be able to complete all test procedures;<br>(2) Age 18-75 years old, gender is not limited;<br>(3) Patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma proved by histopathology to be unable to undergo radical gastrectomy;<br>(4) Patients in cohort 2 had at least one metastatic lesion suitable for SBRT (bone metastasis cannot be used as a radiotherapy lesion);<br>(5) HER2 negative;<br>(6) Pre-treatment staging assessment by endoscopic ultrasound, enhanced CT/MRI, and laparoscopic exploration was performed for patients with stage IV according to AJCC Version 8;<br>(7) have not received any antitumor therapy before;<br>(8) Expected survival =6 months;<br>(9) Card score =70, ECOG score: 0-1;<br>(10) Good liver and kidney function and bone marrow function, laboratory test standards are as follows:<br>Total bilirubin =1.5 times the upper limit of normal (ULN);<br>Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 times ULN;<br>Alkaline phosphatase =2.5 times ULN (=3 times ULN if the tumor has intrahepatic invasion);<br>Serum creatinine =1.5 ULN, Ccr= 60 mL/min;<br>Serum amylase and lipase = 1.5x ULN;<br>International Standardized ratio (INR)/Partial prothrombin time (PTT) =1.5 times ULN;<br>Have not received blood transfusion or isotropic blood cell intervention with stimulating factors at least 2 weeks prior to administration, and have platelet counts =75,000 /mm3;<br>Hemoglobin = 9 g/dL;<br>Neutrophil count = 1500/mm3;<br>(11) no other serious medical complications;<br>(12) Female subjects of reproductive age or male subjects whose sexual partner is a female of reproductive age should take effective contraceptive measures during the entire treatment period and 6 months after the treatment period;<br>(13) Agree to provide tissue examination specimens (to detect PD-L1 expression, tumor mutation load, etc.).

Exclusion Criteria

(1) HER2 positive;<br>(2) is conducting other drug clinical trials, or participated in any drug clinical trials 1 month before enrollment;<br>(3) Present with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, nephritis, hyperthyroidism, hypothyroidism);<br>(4) those who were using immunosuppressants or hormone therapy (systemic or local) for immunosuppressive purposes and continued to use it within 2 weeks prior to enrollment;<br>(5) Human immunodeficiency virus (HIV) infected persons (HIV 1/2 antibody positive), known syphilis infected persons (TPPA positive);<br>(6) any uncontrolled active infection, including but not limited to active tuberculosis; Those who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to the first dosing;<br>(7) Known to have acute or chronic active hepatitis B (HBsAg positive with HBV DNA=2000IU/mL or =104 copy number /mL) or acute or chronic active hepatitis C (HCV antibody positive with<br>HCV RNA positive);<br>(8) Active or clinically significant heart disease:<br>Congestive heart failure - New York College of Cardiology (NYHA) > Class II;<br>(10) Active coronary artery disease;<br>(11) arrhythmias requiring treatment other than beta-blockers or digoxin;<br>(12) Unstable angina pectoris (angina symptoms at rest), new angina pectoris within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment;<br>(13) Have bleeding/clotting disease or history;<br>(14) = grade 3 bleeding events 4 weeks before enrollment;<br>(15) Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, occurred in the 6 months prior to enrollment;<br>(16) Taking anticoagulants;<br>(17) Gastrointestinal perforation, gastrointestinal obstruction, or uncontrolled diarrhea during the 6 months prior to enrollment;<br>(18) Have untreated or co-existing tumors other than cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumor. If the tumor has been eradicated and there is no evidence of disease for more than 3 years, they can be enrolled. Treatment of all other tumors must be completed at least 3 years before enrollment.<br>(19) pleural effusion, ascites, pericardial effusion with clinical symptoms or requiring drainage, except for radiographic evidence showing a small amount of pleural effusion, a small amount of ascites, and a small amount of pericardial effusion without clinical symptoms;<br>(20) pheochromocytoma patients;<br>(21) symptomatic brain metastases or meningiomas;<br>(22) unhealed wounds, ulcers or fractures;<br>(23) Patients with renal failure who require blood or peritoneal dialysis;<br>(24) Patients with epilepsy who require medication;<br>(25) Activity causing dyspnea (= grade 2 dyspnea), symptomatic interstitial lung disease, pleural effusion, or ascites;<br>(26) History of organ transplantation (including corneal transplantation);<br>(27) Allergy or suspected allergy to the investigational drug or similar drug;<br>(28) Pregnant or lactating women;<br>(29) Substance abuse, medical, psychological, or social conditions that affect patient enrollment and evaluation of experimental results;<br>(30) Other anti-tumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) in addition to the investigational drug during treatment;<br>(31) Previous use of similar chemotherapy drugs or immune checkpoint

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety;Tolerability;

Secondary Outcome Measures

Name	Time	Method
Progression free survival;Objective response rate;Disease control rate;Duration of response;Overall survival;