Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

Trial Title: Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

NCT ID: NCT06122493

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin

Conditions: Keywords:
ESCC
cN3
radiotherapy
chemotherapy
immunotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Chemotherapy includes carboplatin (AUC = 5, d1) and nab-paclitaxel (175 mg/m², day1) every 3 weeks for four cycles. Simultaneously, immunotherapy with tislelizumab (200 mg) is integrated into the treatment plan for these cycles. After the initial four cycles, patients have physical exams and imaging. Those with SD, PR, or CR receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy over 28 fractions. During radiotherapy, two additional cycles of immunotherapy with tislelizumab are given at three-week intervals. After radiotherapy, patients continue with maintenance treatment, taking tislelizumab every three weeks. This maintenance therapy lasts up to a year, or until disease progression or intolerance develops.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tirelizumab
Description: immunotherapy, 200 mg on day 1 per 3 weeks
Arm group label: chemotherapy-immunotherapy-radiotherapy

Other name: anti-PD-1 monoclonal antibody

Intervention type: Drug
Intervention name: Nab paclitaxel
Description: chemotherapy, 175 mg/m² on day 1 per 3 weeks
Arm group label: chemotherapy-immunotherapy-radiotherapy

Other name: Chemotherapy drug

Intervention type: Drug
Intervention name: Carboplatin
Description: chemotherapy, AUC=5 on day 1 per 3 weeks
Arm group label: chemotherapy-immunotherapy-radiotherapy

Other name: Chemotherapy drug

Intervention type: Radiation
Intervention name: Radiotherapy
Description: Patients without disease progression after four cycles of chemoimmunotherapy receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy delivered over 28 fractions.
Arm group label: chemotherapy-immunotherapy-radiotherapy

Other name: Locoregional therapy

Summary: This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase. The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.

Detailed description: Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy. Those without disease progression then get definitive radiotherapy with immune maintenance therapy for up to 12 months.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Esophageal squamous cell carcinoma confirmed through histopathology. - Distant metastasis excluded by CT, MRI, or PET/CT examinations. - Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0. - Expected survival time of at least 6 months. - With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that could impact radiotherapy progress. - Adequate function of major organs: Hematopoietic function: Hemoglobin ≥100g/L, platelets ≥90×109/L, white blood cells ≥4×109/L. Exceptions may be considered for patients with ECOG 0-1 who have a history of chronic anemia (80-100 g/L), previous low white blood cell levels (3-4×109/L), or reduced platelets (80-90×109/L). Liver function: ALT and AST <1.5 times the upper limit of normal (ULN), bilirubin <1.5×ULN. Renal function: Serum creatinine (SCR) ≤140 μmol/L. - Patients are required to provide informed consent to undergo treatment. Exclusion Criteria: - Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of the primary tumor. - Lack of histological or cytological diagnosis for esophageal cancer. - Previous chest radiotherapy. - Suffering from innate or acquired immune function defects; - Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status, including those on antiretroviral treatment; Chronic hepatitis B with viral replication phase; Active phase of hepatitis C; Active syphilis with a history of mental illness that may hinder treatment completion. - Poor overall health status, defined as KPS < 70 or ECOG > 2. - Presence of severe comorbidities that could impact radiotherapy progress, including: Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; Acute bacterial or systemic fungal infections; Exacerbation of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization; Hepatic or renal insufficiency; Immunosuppressed patients; Coexisting connective tissue diseases, such as active scleroderma or lupus, which are contraindications to radiotherapy. - Inability to comprehend the treatment's purpose or unwillingness to sign the treatment consent form. - Lack of legal capacity or limited legal capacity.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ruijin hospital, Shanghai jiaotong university school of medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Status: Recruiting

Contact:
Last name: Shengguang Zhao

Investigator:
Last name: Shengguang Zhao
Email: Principal Investigator

Investigator:
Last name: Shuyan Li
Email: Sub-Investigator

Start date: November 1, 2022

Completion date: November 1, 2026

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06122493