IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

Exclusion Criteria

• •Esophageal squamous cell carcinoma known to be prone to complete obstruction under endoscopy requires interventional therapy to relieve the obstruction;
• •After stent implantation in esophagus or trachea; Patients who are at high risk of bleeding or perforation due to significant tumor invasion of adjacent organs (aorta or trachea), or who have developed fistulas;
• •Malignant diseases other than esophageal cancer diagnosed within 3 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection);
• •An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• •Allergy to Sintilimab, IBI110 active ingredients or excipients of this study is known;
• •Prior treatment with anti-LAG-3 antibodies;
• •Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
• •Received the following treatment:
• •1. Received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal therapy with anti-tumor indications), etc.;
• •2. Received any investigational drug therapy within 4 weeks prior to treatment;
• •3. Receiving excessive doses of immunosuppressive drugs (systemic corticosteroids exceeding 10mg/ day of prednisone or its equivalent) within 4 weeks prior to treatment;
• •4. Received live attenuated vaccine within 4 weeks prior to treatment (or plan to receive live attenuated vaccine during the study period);
• •5. Major surgery, or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to treatment.
• •An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• •Known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• •People who are known to be allergic to the active ingredient or excipient of Sintilimab in this study;
• •Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
• •Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive);
• •Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);
• •Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• •1. HBV viral load \<1000 copies /ml (200IU/ml) prior to initial administration, subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment to avoid viral reactivation
• •2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
• •Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
• •Pregnant or lactating women;
• •The presence of any serious or uncontrolled systemic disease, such as:
• •1. The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;
• •2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥2 chronic heart failure;
• •3. Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;
• •4. Poor blood pressure control (systolic \> 140mmHg, diastolic \> 90mmHg);
• •5. There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first administration, or there is currently clinically active interstitial lung disease;
• •6. Active pulmonary tuberculosis;
• •7. There is an active or uncontrolled infection that requires systemic treatment;
• •8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
• •9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• •10. Poor diabetes control (fasting blood glucose (FBG) \> 10mmol/L);
• •11. Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \> 1.0g;
• •12. Patients with mental disorders who cannot cooperate with treatment;
• •Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.