A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.
Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.
Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.
This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.
Inclusion Criteria:
Exclusion Criteria:
Surgery for esophageal cancer;
Esophageal fistulae due to infiltration of the primary tumour;
Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
Major surgery or severe trauma within 4 weeks prior to first use of study drug;
Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
Received or receiving any of the following treatments in the past:
Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
Diagnosis of immunodeficiency, including positive HIV test,other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
Severe infections (CTCAE > Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;
History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);
Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;
Known hypersensitivity to large protein preparations, or to any of the components of nab-paclitaxel or carboplatin or to any of the components used within their preparations;
Any other malignant tumor was diagnosed before the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate > 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
Pregnant or lactating patients;
After the researchers' judgment, the subjects have other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having other serious diseases recently (such as myocardial infarction, cerebrovascular accident) that are considered to have a high risk of recurrence, severely abnormal laboratory test values, family or social factors. Situations that may affect the safety of the subjects or the collection of experimental data.
wczhang@tmu.edu.cn02223340123 ext. 1121
Induction Immunochemotherapy + CRT 1. Induction immunochemotherapy: Nab-paclitaxel:220mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Adebrelimab:1200mg, IV,d1, d22. 2. Concurrent chemoradiotherapy: Nab-paclitaxel:175mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Radiotherapy:50.4Gy/1.8Gy/28f. 3. Immunotherapy maintenance: Adebrelimab:1200mg, IV,q3w, until PD or for a maximum of 15 cycles.
CRT + Immunotherapy 1. Concurrent chemoradiotherapy: Nab-paclitaxel:175mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Radiotherapy:50.4Gy/1.8Gy/28f. 2. Immunotherapy maintenance: Adebrelimab:1200mg, IV,q3w, until PD or for a maximum of 17 cycles.
Beijing, Beijing Municipality, China
wangqifeng@scszlyy.org.cn
wczhang@tmu.edu.cn02223340123
Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.
A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer
Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial