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Clinical trial

The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, an Open, Prospective, Single-arm Phase II Study

ID
Name
Immune consolidation therapy
Description
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.
Trial arms
Trial start
2020-08-03
Estimated PCD
2023-08-04
Trial end
2023-12-03
Status
Recruiting
Phase
Early phase I
Treatment
Sintilimab
Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
Arms:
Definitive concurrent chemoradiotherapy or radiotherapy arm
Size
40
Primary endpoint
Percentage of patients with disease progression within 2 years after treatment
2-years
Eligibility criteria
Inclusion Criteria: * ECOG 0-1; Life expectancy \>6 months; * Stage II/III esophageal cancer; * Pathology confirmed squamous cell carcinoma; * Hemoglobin ≥10g/dl, WBC ≥3.0 x 109/L, platelet ≥100 x 109/L; CR≤ 1.0x normal upper limit, total bilirubin ≤ 1.5x normal upper limit, AST and ALT≤ 1.5x normal upper limit, AKP≤ 2.5x normal upper limit; * Have a full understanding of this study, participate voluntarily, have follow-up conditions and sign the informed consent; Exclusion Criteria: * Stage IV esophageal cancer; * Esophageal adenocarcinoma; * Gastric esophageal junction adenocarcinoma; * ECOG \> 2; * Progression after first-course radiotherapy; * Existing active infection, such as active tuberculosis, hepatitis, etc.;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single arm phase II study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-04-28

1 organization

1 drug

1 indication

Organization
Wuhan University
Drug
PD-1 antibody
Indication
Esophageal squamous cell carcinoma