Esophageal cancer
Conditions
Interventions
Experimental group:Irinotecan Liposome (II) + Camrelizumab + Fluorouracil-based Drugs
Sponsors
Affiliated Hospital of Yangzhou Univrtsity
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old (calculated based on the date of signing the informed consent form), regardless of gender; 2. Unresectable locally advanced, locally recurrent or metastatic esophageal squamous cell carcinoma diagnosed by histopathology and/or cytology; 3. Previous first-line standard treatment for esophageal squamous cell carcinoma and treatment failure or intolerance: A) Treatment failure or intolerance refers to: a. disease progression during treatment or after the last treatment, and there must be clear evidence of imaging or clinical progression; b. For patients who withdrew from standard treatment due to intolerance of adverse events, according to CTCAE 5.0 criteria, the intolerable adverse events refer to hematologic toxicity >= Grade IV or non-hematologic toxicity >= Grade III or damage to major organs such as heart, liver and kidney >= Grade II; b) The following treatment methods are not included in receiving first-line standard treatment: a. Treatment used in the neoadjuvant treatment stage; b. Recurrence more than 6 months after completion of adjuvant therapy (if recurrence occurs during adjuvant therapy or within 6 months after completion of treatment, it will be counted); 4. According to the RECIST v1.1 standard, there is at least one measurable lesion, and the measurable lesion has not received radiotherapy or other local treatment, unless it progresses after the treatment is completed (that is, the target lesion should not receive radiotherapy or other local treatment. If the lesion in the previous radiotherapy area is located, if it is confirmed to have progressed and meets the RECIST v1.1 standard, it can also be the target lesion); 5. Expected survival time >= 3 months; 6. The performance status score of the Eastern United States Cooperative Oncology Group (ECOG) is 0 ~ 1; 7. Meet the basic requirements of combination therapy, including basically normal peripheral blood picture, no obvious abnormalities in heart, liver and kidney function, and basically normal electrocardiogram, that is, the organ function level and related laboratory indicators of the subject within 14 days before the start of study treatment must meet the following requirements: A) Blood routine: absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; Hemoglobin (Hb) >= 90 g/L. Within 14 days before screening, no blood transfusion or hematopoietic stimulating factor drugs were used for correction. b) Blood biochemistry: serum albumin (ALB) >= 30 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50%); d) Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) <= 1.5 × ULN, international normalized ratio (INR) <= 1.5 × ULN (previous anticoagulation therapy; for use of stable doses of anticoagulation therapy such as low molecular weight heparin or warfarin and international normalized ratio [INR] within the expected therapeutic range of anticoagulants can be screened). 8. Voluntarily partic
Exclusion criteria
Exclusion criteria: 1. Tumor and treatment related: 1) Had had a malignant tumor other than esophageal cancer within 5 years prior to screening (except cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, malignant tumors with low risk of metastasis and death assessed by the investigator); 2) For patients with known central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance (MRI) examination must be performed within 28 days before starting study treatment to rule out central nervous system metastases; 3) Previous irinotecan/irinotecan liposome-based chemotherapy; 4) use of strong inhibitors/inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to initiation of study treatment; 5) Participated in other drug clinical trials within 4 weeks before starting study treatment, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 2. Medical history or co-diseases: 1) Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; inflammation of NCI-CTCAE v5.0 > Grade 2; diarrhea of NCI-CTCAE v5.0 > Grade 1), or other conditions that may affect the intake, transport or absorption of drugs according to the investigator's judgment (including inability to swallow; after small bowel resection or total gastrectomy, etc.); 2) pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0 >= Grade 2); 3) Presence of severe comorbidities that hinder treatment with the investigational drug: A) uncontrolled serious medical conditions that the investigator believes will affect the subject's ability to receive treatment under the study protocol, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, active peptic ulcer, etc.; b) Arterial/venous thrombosis events occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except those who have recovered from venous thrombosis caused by venous catheterization in the early stage of chemotherapy and judged by the investigator) and pulmonary embolism, etc.; c) Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the patient's tumor has a high probability of invading important blood vessels and causing fatal bleeding during treatment; d) Previous interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormones; e) Clinical symptoms or diseases of the heart that are not well controlled, such as: New York Heart Association (NYHA) Grade 2 or higher heart failure; Unstable angina pectoris; Myocardial infarction within 6 months; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; f) hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive; 4) Serious infection (NCI-CTCAE v5.0 > Grade 2) within 4 weeks before screening, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.; The presence of symptoms and signs of infection within 2 weeks prior to the start of study treatment required intravenous antibiotic treatment (except for prophylactic use of antibiotics). 3. Other:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Safety evaluation; | — |
Countries
China
Contacts
Public ContactChen Yong
Affiliated Hospital of Yangzhou Univrtsity
Outcome results
None listed