Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal … (NCT07469241) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma.
50 participantsStarted 2026-03-10
Plain-language summary
FUTURE-3 was a prospective, multicenter, single-arm phase II study designed to explore the efficacy and safety of MRI-guided individualized chemoradiotherapy for locally advanced esophageal squamous cell carcinoma. The primary endpoint was one-year progression-free survival rate.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Obtain written informed consent before any trial-related procedures are implemented;
* Age 18-80 years;
* ECOG performance status score: 0-2 points;
* Pathologically confirmed esophageal squamous cell carcinoma;
* Locally advanced stage, unresectable or refusing surgery, and stage IV with only extra-regional lymph node metastasis;
* Tolerance of contrast-enhanced MRI;
* Expected survival \> 3 months;
* Adequate organ function; subjects must meet the following laboratory criteria:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L;
* Platelet count ≥ 100 × 10⁹/L.
* Hemoglobin \> 9 g/dL;
* Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
* Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml/min;
* Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;
* Normal thyroid function, defined as TSH within the normal range. If baseline TSH is outside the normal range, subjects with normal total T3 (or FT3) and FT4 may also be enrolled;
* Cardiac enzyme levels are within the normal range (simple laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled);
* For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to the first administration of the stud…