esophageal squamous carcinoma ,
Conditions
Interventions
Cohort 1 consisted of patients who had received PD-1 immunotherapy in the first line and received immune rechallenge in the second line:Camrelizumab (200mg, d1) and albumin-bound paclitaxel (125mg/m2,
Cohort 2 consisted of patients who had not received immunotherapy in the first line and received immunotherapy in the second line:Camrelizumab (200mg, d1) and albumin-bound paclitaxel (125mg/m2, d1, d
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, male or female; 2. Patients with locally recurrent or metastatic esophageal squamous cell carcinoma who have failed or are intolerable to previous first-line therapy (including chemotherapy failure and PD-1 disease progression); 3. No previous albumin-bound paclitaxel treatment; (4) For patients who had received previous immunotherapy, the best response evaluation of initial immunotherapy was CR, PR, or SD=3 months; 5. At least one measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST 1.1); 6. ECOG PS score: 0-1; 7. Expected survival time =12 weeks; 8. Major organ function within 7 days before treatment, meet the following criteria: a. Blood routine test criteria (without blood transfusion within 14 days) : ? Hemoglobin (HB) =90g/L; ? Absolute neutrophil count (ANC) =1.5×109/L; ? Platelet (PLT) =80×109/L. b. Biochemical tests must meet the following criteria: ? Total bilirubin (TBIL) =3 times upper limit of normal value (ULN); ? alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5ULN; ? Serum creatinine (Cr) =1.5ULN or creatinine clearance (CCr)=60mL/min; c. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)= the lower limit of normal (50%). 9. Women of childbearing potential should agree that they must use an effective contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; A negative serum pregnancy test within 72 hours before the first dose and must be nonlactating; Men should agree that effective contraception must be used during the study period and for 6 months after the study period. 10. No active uncontrolled infection except for chronic viral hepatitis receiving antiviral treatment; 11. Patients voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not eligible for the study: 1. Patients with contraindications to restart immunotherapy; 2. BMI 10 mg prednisone equivalent daily) within 2 weeks prior to the first dose of study drug. Other special circumstances require communication with the sponsor. Inhaled or topical steroids and adrenocortical hormone replacement at a therapeutic dose of 10 mg per day or less of prednisone were allowed in the absence of active autoimmune disease. e. persons who have received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of study drug; f. Major surgery or major trauma within 4 weeks before the first dose of study drug; 10. Severe infection (CTC AE > 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on baseline chest imaging, symptoms and signs of infection within 2 weeks before the first dose of study drug, or the need for oral or intravenous antibiotics. 11. History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia; 12. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis inf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of response;Safety; | — |
Countries
China
Contacts
Public ContactLinlin.Wang
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Prevention and Treatment Institute)
Outcome results
None listed