Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

NCT06122493 | Recruiting Phase 2

• 1 other identifier: RuijinH 2022(270)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

ESCC; cN3; radiotherapy; chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival

  From the initial administration of the study drug to the first identification of disease progression or mortality, whichever happens first. In the case of patients who had not encountered local control failure or death, specifically in terms of progression-free survival, the time of the last tumor assessment was considered as the endpoint. Tumor response was evaluated by investigators following RECIST v1.1 criteria.

  1 year

Secondary Outcomes (7)

• Acute toxicity

  3 months

• Quality of Life (QoL)

  1 years

• Objective response rate

  1 year

• Duration of response

  1 year

• Disease control rate

  1 year

Study Arms (1)

chemotherapy-immunotherapy-radiotherapy

OTHER

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.

Drug: Tirelizumab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

Interventions

Tirelizumab DRUG

immunotherapy, 200 mg on day 1 per 3 weeks

Also known as: anti-PD-1 monoclonal antibody

chemotherapy-immunotherapy-radiotherapy

Nab paclitaxel DRUG

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

Also known as: Chemotherapy drug

chemotherapy-immunotherapy-radiotherapy

Carboplatin DRUG

chemotherapy, AUC=5 on day 1 per 3 weeks

Also known as: Chemotherapy drug

chemotherapy-immunotherapy-radiotherapy

Radiotherapy 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.

Also known as: Locoregional therapy

chemotherapy-immunotherapy-radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

spartalizumab; Taxes; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Coordination Complexes; Organic Chemicals; Therapeutics

Central Study Contacts

Yifeng Wang

CONTACT

0086-021-64370045; ruijincrc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 8, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)