A Phase 2 interventional study of Sintilimab in Esophageal Squamous Cell Carcinoma, sponsored by Wuhan University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Wuhan University · Phase 2, Interventional, and Treatment
Esophageal cancer is a kind of disease with high incidence and mortality. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma. To Investigate the value of immunotherapy consolidation in locally advanced esophageal squamous cell carcinoma after completing radical concurrent chemoradiotherapy.
In East countries, especially China, more than 75 percent of esophageal cancers are primary squamous cell cancers located in the middle and upper thoracic segments, whereas adenocarcinoma accounted for less than 20 percent.Unlike other malignancies, more than half of esophageal cancer were diagnosed as locally advanced at the time of diagnosis. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma.
Immune checkpoint inhibitors are a new class of antitumor drugs. They are different from traditional cytotoxic chemotherapy drugs and can target the regulatory molecules that play an inhibitory role in the tumor immune system.
Recent clinical studies had shown that for locally advanced non-small cell lung cancer, maintenance therapy with the immune checkpoint inhibitor could significantly improve the overall survival for locally advanced non-small cell lung cancer after definitive concurrent chemoradiotherapy. Moreover, the immune checkpoint inhibitor PD-1 has also been shown to be a promising anticancer agent in esophageal cancers. Therefore, the present study intended to give a standard dose (50.4Gy/28F) to locally advanced esophageal squamous cell carcinoma for radical chemoradiotherapy, and than to give the Sintilimab as consolidation therapy for 1 year after completion of radiotherapy. At the time point of 6 weeks after radiotherapy, all participates need a full evaluation of the treatment response. In patients with residual disease, we would give them an additional radiotherapy boost to 61.2 Gy/34F under the guidance of PET-CT or ultrasound endoscopy.
657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Wuhan University is the lead sponsor of 46 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Drug: Sintilimab
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Percentage of patients with disease progression within 2 years after treatment
Progression-free survival is measured from the date of enrolling to the date of disease progression or death from any cause or final follow-up
Time frame: 2-years
Percentage of patients who died within 2 years after treatment
Progression-free survival is measured from the date of enrolling to the date of death from any cause or final follow-up
Time frame: 2-years
The number of patients with treatment-related toxicity between the treatment period and half a year after treatment
Acute toxicities were scored according to the Common Toxicity Criteria for Adverse Events, version 3.0 (National Cancer Institute, NCI, Rockville, MD).
Time frame: 0.5-year
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sintilimab
Esophageal Squamous Cell Carcinoma →
Wuhan University