Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Concurrent chemoradiotherapy (cCRT)

    Combination product

    concurrent chemoradiotherapy

  • Induced treatment

    Drug

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Personalized Chemoradiotherapy and ImmunotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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