Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

  • End date
    Jun 30, 2028
  • participants needed
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 11 April 2023


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.


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, 3week2cycles; DDP 75mg/m2 ivgtt, d2, 3week2cycles; 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

Condition Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug
Treatment Consolidation chemotherapy (4 courses), Concurrent chemotherapy (2 courses)
Clinical Study IdentifierNCT05775419
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on11 April 2023


Yes No Not Sure

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
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