About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Enhanced MRI showing a primary esophageal lesion thickness less than 5 mm and a short diameter lymph node less than 1 cm.
Severe emphysema, interstitial lung disease, or COPD.
History of other malignant tumors and chemotherapy within the past 2 years.
History of chest radiotherapy.
Trial design
Single group
Treatments tested in this trial
Concurrent chemoradiotherapy (cCRT)
Combination productconcurrent chemoradiotherapy
Induced treatment
DrugTPF (Paclitaxel micelles or albumin-bound paclitaxel 100 mg/m2, cisplatin 30 mg/m2, fluorouracil 200 mg/m2 IV drip + 1000 mg/m2 pump for 44 hours, leucovorin/calcium 200 mg) + Adebrelimab 1200mg
Treatment groups
Trial outcomes
Primary outcomes
1-year PFS rate
PFS refers to the time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause (whichever comes first).
Secondary outcomes
ORR
The ORR (Objective response rate) refers to the proportion of patients whose tumor volume shrinks to a predetermined value and can be maintained for the minimum required period is the sum of the proportions of complete remission and partial remission. The remission period usually refers to the time from the onset of therapeutic efficacy until the confirmation of tumor progression.
PFS
Progression-Free survial (PFS) refers to the time from the start of randomization (or the start of treatment in a single-arm trial) to tumor progression or death from any cause (whichever comes first).
OS
Overall suvival refers to the time from the start of randomization (or the start of treatment in a single-arm trial) to death from any cause.
Local recurrence rate
Localized recurrence refers to the recurrence of esophageal cancer at the site of the primary lesion and in the surrounding lymph nodes.
Locations
Sponsors and contacts
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