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โ† Trials
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Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

RecruitingNAAges 18 Years - 70 YearsAllThe First Affiliated Hospital with Nanjing Medicaโ€ฆ
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In plain words

What the trial is, and whether it could suit you

This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-70 years old, not limited to male or female; at least able to take liquid diet; 2. Esophageal squamous cell carcinoma proved by histopathology; 3. Esophageal squamous cell carcinoma that is inoperable or refuses surgery, 4. According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage; 5. ECOG 0-1; life expectancy \> 6 months; 6. No chemotherapy was used before selection; 7. No history of radiotherapy; 8. No surgical treatment; 9. No serious allergic history; 10. 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: 1. History of malignant tumors in other parts; 2. Duplicate carcinoma of the esophagus; 3. Pregnant or lactating patients; 4. Fertility but not using contraceptive measures; 5. Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function โ‰ฅ grade II, mental history and severe diabetes; 6. During the active period of infectious diseases; 7. Participate in other clinical trials at present or within four weeks before enrollment; 8. Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine); 9. After esophageal stent placement; 10. Cases with perforation tendency; 11. Have a history of organ transplantation. 12. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases; 13. 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.
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What it tests

  • Consolidation chemotherapy (4 courses)
  • Concurrent chemotherapy (2 courses)
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Where

1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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