AzTrials
AzTrials

Advanced Esophageal Squamous Cell CarcinomaPhase 2FUTURE-3NCT07469241

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

A Phase 2 study testing Concurrent chemoradiotherapy (cCRT) and Induced treatment in people with Advanced Esophageal Squamous Cell Carcinoma and Unresectable Esophageal Squamous Cell Carcinoma, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Concurrent chemoradiotherapy (cCRT) and Induced treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
10 Mar 2026to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 19Show fewer
  • 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 study drug (day 1 of cycle 1), and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-age women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;
  • If there is a risk of pregnancy, all subjects (regardless of gender) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.
  • Pregnant or lactating women;
  • Presence of any serious or uncontrollable systemic disease, such as:
  • Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;
  • Unstable angina, congestive heart failure, or chronic heart failure with a New York Heart Association (NYHA) classification ≥2;
  • Any arterial thrombosis, embolism, or ischemia that has occurred within 6 months prior to enrollment in treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
  • Poorly controlled blood pressure (systolic blood pressure >140 mmHg, diastolic blood pressure >140 mmHg).
  • History of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to the first dose, or current clinically active interstitial lung disease;
  • Active pulmonary tuberculosis;
  • Active or uncontrolled infection requiring systemic treatment;
  • Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
  • Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis;
  • Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L);
  • Urinalysis showing ≥++ proteinuria, and 24-hour urine protein quantification > 1.0 g;
  • Patients with mental disorders who cannot cooperate with treatment;
  • Medical history or disease evidence, treatment or abnormal laboratory test values that may interfere with trial results or prevent full participation of subjects in the study, or other circumstances deemed unsuitable for enrollment by the investigator.

About this study

Official title: MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma: A Prospective, Multicenter, Single Arm, Phase II Study (FUTURE-3)

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.

Read the detailed description

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.

Being tested
Concurrent chemoradiotherapy (cCRT), Induced treatment
Keywords
Limited Advanced Esophageal Squamous Caicinoma, MRI-guided, Chemoradiotherapy, adebrelimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concurrent chemoradiotherapy (cCRT)Combination product

    concurrent chemoradiotherapy

  • Induced treatmentDrug

    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

Study groups in NCT07469241
Study groupRoleWhat they receive
Personalized Chemoradiotherapy and ImmunotherapyExperimentalPatients 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.
Receives: Combination Product: Concurrent chemoradiotherapy (cCRT); Drug: Induced treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (11)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 24months

  5. 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.

    Measured: 24months

  6. 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.

    Measured: 24months

  7. 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).

    Measured: 24months

  8. 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.

    Measured: 24months

  9. Number of myeloid-derived suppressor cells

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

  10. Number of dendritic cells

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

  11. Number of T cells

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start10 Mar 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469241
Sponsor's protocol ID
2601337-22
Acronym
FUTURE-3
Status last verified
Mar 2026
First submitted
24 Feb 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Concurrent chemoradiotherapy (cCRT) and Induced treatment in people with Advanced Esophageal Squamous Cell Carcinoma and Unresectable Esophageal Squamous Cell Carcinoma, run by Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year PFS rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in