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临床试验 NCT07469241 (FUTURE-3) 针对晚期食管鳞状细胞癌，不可切除的食管鳞状细胞癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
复旦大学Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma. (FUTURE-3) II期 50 免疫疗法
MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma: A Prospective, Multicenter, Single Arm, Phase II Study (FUTURE-3)
- FUTURE-3
- 2601337-22
MRI-guided
Chemoradiotherapy
adebrelimab
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Personalized Chemoradiotherapy and Immunotherapy 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. | Concurrent chemoradiotherapy (cCRT) concurrent chemoradiotherapy Induced treatment 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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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). | 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. | 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. | 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. | 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. | 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). | 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. | 24months |
Number of myeloid-derived suppressor cells | At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days) | |
Number of dendritic cells | At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days) | |
Number of T cells | At the end of Cycle 1, Cycle 4, and one month after Cycle 4(each cycle is 21 days) |
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;
- 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).
- 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.
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.
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