Advanced esophageal squamous cell carcinoma
Conditions
Interventions
Single-Arm:I125 radioactive particle stent combined with immune checkpoint inhibitors
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 80 years, both male and female acceptable; 2.Histologically or cytologically confirmed advanced esophageal squamous cell carcinoma; 3.Unsuitable for or unable to tolerate radical treatments (such as surgery, curative radiotherapy or chemotherapy), and no standard treatment available or unable to tolerate standard treatment. "No standard treatment available or unable to tolerate standard treatment" is defined as meeting any of the following criteria: (1). Previously received at least one line of standard systemic treatment for advanced/metastatic disease with disease progression or recurrence; (2). Unable to receive existing first-line standard treatment due to definite contraindications (such as severe myelosuppression, renal insufficiency, allergy, etc.); (3). Patient explicitly refuses standard first-line treatment, and after investigator assessment, the study protocol is considered a reasonable alternative. 4.Expected survival time >= 3 months; 5.Dysphagia score >= 2; 6.Key organ functions meet the following requirements: absolute neutrophil count >= 1.5 × 10^9/L; platelets >= 80 × 10^9/L; hemoglobin >= 80 g/L; total bilirubin <= 1.5 × upper limit of normal (ULN); serum creatinine within normal limits; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN; 7.For female subjects of childbearing potential and male subjects with partners of childbearing potential, a medically approved method of contraception must be used during the study treatment period; 8.Subjects voluntarily join the study, sign an informed consent form, show good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Previous radiotherapy to the esophageal lesion; 2.Known hypersensitivity or allergic reaction to any component of biologics produced by Chinese Hamster Ovary (CHO) cells or PD-1 monoclonal antibody preparations; 3.Severe cardiac, renal, or hepatic insufficiency that cannot tolerate the treatment; 4.Subjects who required systemic treatment with corticosteroids (equivalent to 10 mg of prednisone per day) or immunosuppressive agents within 2 weeks before the first use of the investigational drug, except for local esophageal inflammation, allergy prevention, or nausea and vomiting. Topical or inhaled steroids are allowed in the absence of active autoimmune diseases. If patients need unexpected immunosuppressive medication during the trial, it will be permitted but strongly recommended to reduce the dosage as soon as possible; 5.Individuals who have received anti-tumor vaccines or live vaccines within 4 weeks before the first dose of the investigational drug; 6.Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes), except for vitiligo or childhood asthma/allergies that have resolved without any intervention in adulthood; autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; type 1 diabetes treated with a stable dose of insulin (patients with controlled blood glucose under a stable insulin regimen may be enrolled in this study); 7.History of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; 8.Subjects with poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1). Heart failure of NYHA class II or above; (2). Unstable angina; (3). Myocardial infarction within the past year;(4). Clinically significant supraventricular or ventricular arrhythmia that is not clinically managed or remains poorly controlled after clinical intervention; 9.Active hepatitis B (chronic or acute; defined as positive hepatitis B surface antigen (HBsAg) during screening and HBV DNA copy number > 1000 cps/ml) or hepatitis C patients; 10.Patients with active tuberculosis (clinical diagnosis includes clinical history, physical examination, imaging findings, and TB tests according to local medical standards); 11.Severe infection (CTCAE grade > 2) within 4 weeks before the first use of the investigational drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging indicates active pulmonary inflammation, signs and symptoms of infection within 2 weeks before the first use of the investigational drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic antibiotic use; 12.Major surgery (excluding diagnostic surgery) within 28 days before treatment, or major surgery expected during the study period; 13.Diagnosis of any other malignancy within 5 years before the first use of the investigational drug, except for low-risk malignancies with a 5-year survival rate > 90%, such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 14.Pregnant or breastfeeding female patients who refuse or are unable to use contraception. 15.Other circumstances deemed unsuita
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month Clinical Patency Rate,3m CPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight Loss-Free Survival,WLFS;Weight Loss-Free Survival,WLFS;Objective Response Rate;Progression-Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactMengxia Li
Army Medical Center of PLA
Outcome results
None listed