A Randomized, Controlled, Multicenter Clinical Study of Camrelizumab in Combination With Apatinib Mesylate and Chemotherapy Versus Camrelizumab Plus Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line
⁃ 1\. Age 18-75, male or female;
⁃ 2\. Esophageal squamous cell carcinoma that is histologically or cytologically confirmed as unresectable locally advanced/recurrent (unable to receive radical treatment such as radical chemoradiotherapy or radical radiotherapy) or distant metastasis;
⁃ 3\. No previous systematic antitumor therapy. For patients who received neoadjuvant/adjuvant and radical concurrent chemoradiotherapy, the time from the last chemotherapy to recurrence or progression more than 6 months can be screened;
⁃ 4\. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there should be at least one measurable lesion (esophageal and other cavity structures cannot be used as measurable lesions), and the measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previous radiotherapy area can also be selected as target lesions if it is confirmed to progress);
⁃ 5\. Agree to provide tissue samples for biomarker (such as PD-L1) analysis. Recently obtained tissues are preferred. Patients who cannot provide recently obtained tissues can provide 5-8 paraffin sections of 3-5 μm thickness for archival storage;
⁃ 6\. ECOG PS: 0 \
• 1;
⁃ 7\. Swallowing pills normally;
⁃ 8\. Expected survival ≥12 weeks;
⁃ 9\. The functions of vital organs meet the following requirements (no drugs with blood components and cell growth factors are allowed to be used within 14 days before the first use of the study drug);
∙ Absolute count of neutrophils (ANC) ≥1.5×109/L
‣ Platelet ≥90×109/L;
‣ Hemoglobin ≥90g/L;
‣ Serum albumin ≥28g/L;
‣ Total bilirubin ≤1.5 × ULN, ALT, AST, and/or AKP≤2.5 × ULN; If liver metastasis is present, ALT and/or AST≤5 × ULN; If there is liver metastasis or bone metastasis AKP≤5 × ULN;
‣ Serum creatinine ≤1.5 × ULN or creatinine clearance \> 60 mL/min (Cockcroft-Gault);
‣ Activated partial thromboplastin time (APTT) and International Normalized ratio (INR) ≤1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the expected treatment range of anticoagulants can be screened)
⁃ 10\. Fertile female subjects and male subjects whose partners are women of childbearing age, A medically approved contraceptive (such as an intrauterine device, contraceptive or condom) is required during the study treatment period and at least 2 months after the last use of carrilizumab/Apatinib mesylate and at least 6 months after the last use of chemotherapy;
⁃ 11\. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.