Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma
This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.
• Sign written informed consent and voluntarily participate in this study;
• Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;
• Survival is expected to exceed 3 months
• Age 18-75;
• ECOG PS 0-2
• Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
• Have at least one measurable lesion
• Normal function of major organs, including:
‣ Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)
‣ White blood cell count ≥ 3.0×10\^9/L
‣ Neutrophil count ≥ 1.0×10\^9/L
‣ Platelet count ≥ 80×109/L
‣ Hemoglobin ≥ 80 g/L
⁃ Blood biochemical examination:
• Total bilirubin ≤ 1.5×ULN
• ALT ≤2.5×ULN, AST ≤2.5×ULN,
• Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min
• Subjects have good compliance and cooperate with follow-up