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

NCT07469241 | Not Yet Recruiting Phase 2

• 1 other identifier: 2601337-22
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Esophageal Squamous Cell Carcinoma; Unresectable Esophageal Squamous Cell Carcinoma

Keywords

Limited Advanced Esophageal Squamous Caicinoma; MRI-guided; Chemoradiotherapy; adebrelimab

Outcome Measures

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).

  12 months

Secondary Outcomes (11)

• ORR

  At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days)

• PFS

  24 month

• OS

  24 months

• Local recurrence rate

  24months

• Intra-radiation field recurrence rate

  24months

Study Arms (1)

Personalized Chemoradiotherapy and Immunotherapy

EXPERIMENTAL

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.

Combination Product: Concurrent chemoradiotherapy (cCRT); Drug: Induced treatment

Interventions

Concurrent chemoradiotherapy (cCRT) COMBINATION_PRODUCT

concurrent chemoradiotherapy

Personalized Chemoradiotherapy and Immunotherapy

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

Personalized Chemoradiotherapy and Immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
• Currently receiving systemic glucocorticoid therapy (excluding nasal sprays, inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.
• Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted.
• Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Known adverse reactions to the study drug. 9) Individuals allergic to the drug or excipients;
• Individuals with a known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive with a detected HBV-DNA copy number greater than the upper limit of normal values in the laboratory of their research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled:
• HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose. Subjects should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation.
• For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary.
• Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit);
• Subjects who received a live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated influenza vaccines for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 13, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03