Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

NCT ID: NCT06122493

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-11-01

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy-immunotherapy-radiotherapy

Carboplatin (AUC = 5, d1) and nab-paclitaxel (175 mg/m², day1) will be administered every 3 weeks for four cycles.Tislelizumab (200 mg) will be administered every 3 weeks for up to 12 months. Radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy over 28 fractions will be delivered.

Group Type: OTHER

Tirelizumab

Intervention Type: DRUG

immunotherapy, 200 mg on day 1 per 3 weeks

Nab paclitaxel

Intervention Type: DRUG

chemotherapy, 175 mg/m² on day 1 per 3 weeks

Carboplatin

Intervention Type: DRUG

chemotherapy, AUC=5 on day 1 per 3 weeks

Radiotherapy

Intervention Type: RADIATION

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.

Interventions

Tirelizumab

immunotherapy, 200 mg on day 1 per 3 weeks

Intervention Type: DRUG

Nab paclitaxel

chemotherapy, 175 mg/m² on day 1 per 3 weeks

Intervention Type: DRUG

Carboplatin

chemotherapy, AUC=5 on day 1 per 3 weeks

Intervention Type: DRUG

Radiotherapy

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.

Intervention Type: RADIATION

Other Intervention Names

anti-PD-1 monoclonal antibody; Chemotherapy drug; Chemotherapy drug; Locoregional therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yifeng Wang

Role: CONTACT

ruijincrc@126.com

0086-021-64370045

Facility Contacts

Shengguang Zhao

Role: primary

Other Identifiers

RuijinH 2022(270)

Identifier Type: -

Identifier Source: org_study_id