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.
In this study, patients will receive two cycles of TPF chemotherapy plus adeberib immunotherapy induction, followed by concurrent chemoradiotherapy. One month after the completion of radiotherapy, adebrelimab immunotherapy will be initiated for two years for maintenance. Based on the results of enhanced MRI, the regimen will be adjusted three times: ① After one chemoradiotherapy induction cycle, if the tumor shrinkage is \<20%, the TPF regimen will be replaced with the FLOT regimen; ② After the completion of radiotherapy, if MRI shows significant residual tumor, CRP \<10 ng/L, and no grade II or higher adverse reactions, maintenance immunotherapy will be initiated immediately; ③ One month after radiotherapy, if MRI shows significant residual tumor, capecitabine metrotherapy will be added, and the radiotherapy dose for residual lesions will be increased.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
concurrent chemoradiotherapy
TPF (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
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).
Time frame: 12 months
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.
Time frame: At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days)
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).
Time frame: 24 month
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.
Time frame: 24 months
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.
Time frame: 24months
Intra-radiation field recurrence rate
The esophageal cancer recurrence rate within the radiation field refers to the proportion of esophageal cancer patients who have undergone radical radiotherapy (or chemoradiotherapy) and whose tumors regrow (recur) within the irradiated area covered by the original radiotherapy plan within a certain period of time after the completion of treatment.
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Time frame: 24months
Outside-radiation field recurrence rate
This refers to the proportion of esophageal cancer patients who, after completing radical radiotherapy (or chemoradiotherapy), experience tumor recurrence in areas outside the irradiated area covered by the original radiotherapy plan during the follow-up period.
Time frame: 24months
Distant metastasis rate
The distant metastasis rate refers to the proportion of malignant tumor patients who, from the time of diagnosis or within a certain follow-up period after treatment (such as 1 year, 3 years, or 5 years), experience hematogenous metastasis, which means that tumor cells spread to other distant organs or tissues of the body through the circulatory system or lymphatic system (ultimately entering the bloodstream).
Time frame: 24months
Adverse reactions
Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 adverse events and higher-grade will be reported.
Time frame: 24months
Number of myeloid-derived suppressor cells
Time frame: At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days)
Number of dendritic cells
Time frame: At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days)
Number of T cells
Time frame: At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days)