Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:I125 radioactive particle stent combined with immune checkpoint inhibitors
Sponsors
Daping Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 80 years old, both genders are eligible; 2. Advanced esophageal squamous cell carcinoma confirmed by histological or cytological examination; 3. Unsuitable or unable to tolerate radical treatment (such as surgery, radical radiotherapy and chemotherapy), and there is no standard treatment or the standard treatment cannot be tolerated. The definition of no standard treatment or inability to tolerate standard treatment is as follows: a. The disease has progressed or recurred after receiving at least one line of systemic standard treatment for advanced/metastatic diseases; Or b. Due to the presence of clear contraindications (such as severe bone marrow suppression, renal dysfunction, allergies, etc.), they are unable to receive the current standard first-line treatment; Or c. The patient explicitly refused to accept the standard first-line treatment, and the investigator assessed that this study protocol was a reasonable alternative option. 4. Expected survival period >= 3 months; 5. Difficulty in swallowing >= 2 points; 6. The functions of important organs meet the following requirements: absolute neutrophil count >= 1.5 × 10^9/L; platelets >= 80 × 10^9/L; hemoglobin >= 80 × 10^9/L; total bilirubin <= 1.5 times the upper limit of normal value; serum creatinine within the normal range; alanine aminotransferase and aspartate aminotransferase <= 2.5 times the upper limit of normal value; 7. Female participants with reproductive capacity, and male participants whose partners are of childbearing age, need to adopt a medically approved contraceptive measure during the study treatment period; 8. Participants voluntarily join this study, sign the informed consent form, have 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 unsuitable for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month Clinical Patency Rate,3m CPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight Loss-Free Survival,WLFS;Swallowing Progression-Free Survival,SPFS;Objective Response Rate,ORR;Progression-Free Survival,PFS;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactMengxia Li
Daping Hospital, Army Medical University
Outcome results
None listed