Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

Test grouping:

Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;

Specific chemotherapy regimens:

Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.

Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life

Inclusion criteria

• Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
• Esophageal squamous cell carcinoma proved by histopathology;
• Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
• According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
• ECOG 0-1; life expectancy > 6 months;
• No chemotherapy was used before selection;
• No history of radiotherapy;
• No surgical treatment;
• No serious allergic history;
• Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;

Exclusion criteria

• History of malignant tumors in other parts;
• Duplicate carcinoma of the esophagus;
• Pregnant or lactating patients;
• Fertility but not using contraceptive measures;
• Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
• During the active period of infectious diseases;
• Participate in other clinical trials at present or within four weeks before enrollment;
• Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
• After esophageal stent placement;
• Cases with perforation tendency;
• Have a history of organ transplantation.
• Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
• Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.