advanced metastatic esophageal squamous cell carcinoma
Conditions
Interventions
Treatment group:SHR8068 combination with adebrelimab and irinotecan liposomes
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participated in this study, signed informed consent, had good compliance, and cooperated with follow-up visits; 2.Aged 18-80 years, including 18 and 80 years, both male and female; 3.Histologically- or cytologically-confirmed diagnosis of advanced metastatic esophageal squamous cell carcinoma; 4.Received previous first-line treatment containing PD-1/PD-L1 monoclonal antibody, and the disease progression was judged by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; 5.At least one measurable lesion based on RECIST 1.1 (esophageal and other cavity structures cannot be used as measurable lesions); 6.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale; 7.Has a life expectancy of greater than 3 months; 8.Fresh or archived tumor tissue samples within 2 years must be provided for biomarker analysis; 9.The function of major organs meets the following criteria(not transfused, not using haematopoietic factors and not corrected with drugs within 14 days):a. Absolute neutrophil count (ANC) >=1.5×10^9/L; b. PLT >=90×10^9/L; c. Hb>=9g/dL; d. ALB>=2.8g/dL; e. total bilirubin =60mL/min (according to Cockcroft-Gault formula); h. international normalized ratio (INR) and activated partial thromboplastin time (APTT) <=1.5×ULN; 10.Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose and agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug. Male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug.
Exclusion criteria
Exclusion criteria: 1.High risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation; 2.Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 3.Serious heart, lung, liver, renal insufficiency, hematopoietic system diseases, endocrine diseases, cachexia, etc. 4.Known to have had a severe allergic reaction to any monoclonal antibody; 5.Patients who ended treatment due to immune-related toxicity during treatment with anti-PD-1 /PD-L1 antibody; 6.Received any of the following treatments: a. Major surgery was studied within 4 weeks before drug treatment; b. Received antitumor therapy within 4 weeks prior to drug treatment; c. Prior treatment with anti-CTLA-4 antibodies or irinotecan; d. Received any investigational drug within 4 weeks prior to first use of the investigational drug; e. Had received the anti-tumor vaccine or resceived the live vaccine within 4 weeks prior to the first use of the investigational drug; f. Patients requiring systemic treatment with corticosteroids ((>10 mg/day of prednisone or equivalent) or other immunosuppressants within 2 weeks prior to first dose, excluding corticosteroids for local esophageal inflammation and prevention of allergy, nausea, and vomiting. Other special cases require communication with the investigators.. 7.The toxicity caused by previous anti-tumor treatments has not recovered to Grade 2) within 4 weeks prior to first dose; 13.Subjects had active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL), active hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of assay); 14.Any other malignancies diagnosed prior to first use of the investigational drug, except those with a low risk of metastasis and risk of death (5-year survival > 90%), such as adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix; 15.Pregnant or lactating women; Fertile subjects who are unwilling or unable to use effective contraception; 16.Patients had other factors that might have led to the forced termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;DCR;PFS;OS;safety; | — |
Countries
China
Contacts
Public ContactTianshu LIU
Zhongshan Hospital, Fudan University
Outcome results
None listed