Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
Esophageal Squamous Cell Carcinoma, Hypofractionated Concurrent Chemoradiotherapy, Conventional Fractionated Concurrent Chemoradiotherapy, Induction chemoimmunotherapy
Brief summary
This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.
Detailed description
This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma. In this study, patients will receive induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab. After induction therapy, they will be randomly assigned to receive either definitive hypofractionated concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy. Following the completion of treatment, patients will undergo regular follow-up to assess efficacy and safety.
Interventions
All patients will receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.
RADIATIONHypofractionated Radiation Therapy
All patients will receive hypofractionated radiotherapy once daily, five days per week, followed by a boost. Three weeks after the completion of the first phase of hypofractionated radiotherapy, tumor response and cardiopulmonary function will be evaluated. For patients who achieve a partial response, have no deep esophageal ulcers on endoscopy, and have cardiopulmonary function tolerating the radiotherapy boost, a second phase of radiotherapy will be planned using a new CT simulation and radiotherapy design. First Phase of Radiotherapy: Total dose of 2500 cGy in 5 fractions (500 cGy per fraction) Second Phase of Radiotherapy: Total dose of 2500 cGy in 10 fractions (250 cGy per fraction) The interval between the two phases of radiotherapy will be 28 days.
RADIATIONConventional Fractionated Radiation Therapy
Patients will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.
DRUGConcurrent Chemotherapy
Capecitabine oral administration, 1000 mg/m², twice daily
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma; * Evaluated as unresectable locally advanced esophageal squamous cell carcinoma by endoscopic ultrasound, imaging studies including esophagography, CT of the neck, chest, and upper abdomen, MRI of the neck and chest, whole-body bone scan, or PET/CT, with staging in the range of II-IVB (stage IVB limited to celiac lymph node or supraclavicular lymph node metastasis); * Male or female aged 18 to 80 years; * Eligible for oral drug therapy; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy; * Tumor sample requirement: Must provide adequate unstained, archived tumor tissue samples for analysis; * Expected survival ≥12 weeks; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; * Postmenopausal women, or women with a negative urine or serum pregnancy test within 14 days before the study drug administration; * Women must not be breastfeeding; * Organ and bone marrow function must meet the following criteria: Forced expiratory volume in 1 second (FEV1) ≥1000 mL; Absolute neutrophil count ≥1.5 × 10\^9/L; Platelets ≥100 × 10\^9/L; Hemoglobin ≥90 g/L; Estimated glomerular filtration rate (eGFR) ≥50 mL/min based on the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; * Signed and dated informed consent must be provided before participation in any study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate | 2 years | The proportion of patients who remain free from disease progression during a defined period after treatment initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 2 years | The proportion of patients who are still alive after a specified period of time, regardless of disease progression or relapse. |
| Clinical response rate | 2 months after radiotherapy | The percentage of patients who had partial remission or complete remission after therapy |
| Rate of grade 3 or higher toxicities | 1 year after therapy | The percentage of patients who develop grade 3 or higher toxicities. The toxicities are evaluated based on Common Terminology Criteria for Adverse Events version 5.0. The values range from 1 to 5. A higher score means a worse outcome. |
| Distant metastasis-free survival rate | 2 years | — |
| Locoregional recurrence-free survival rate | 2 years | — |
Countries
China
Contacts
Primary ContactBo Qiu
Outcome results
None listed