Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma（EC-CRT-003）

Launched by SUN YAT-SEN UNIVERSITY · Aug 21, 2022

Keywords

ClinConnect Summary

This clinical trial, called EC-CRT-003, is studying a new treatment approach for patients with advanced esophageal squamous cell carcinoma that has spread to other parts of the body. The goal is to see if combining chemotherapy and immunotherapy (a type of treatment that helps the immune system fight cancer) with radiation therapy can improve survival and quality of life compared to standard treatments alone. Researchers believe that this combination may work better together than each treatment on its own.

To participate, individuals must be between 18 and 75 years old, have a specific type of esophageal cancer, and have already received some standard chemotherapy without their cancer progressing. They also need to be in good enough health to tolerate the treatments and understand the trial's requirements. Participants can expect to receive close monitoring and care throughout the study. It's important for potential participants to know that there are certain health conditions and previous treatments that may disqualify them from joining the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Eastern Cooperative Oncology Group performance status ≤ 2
• • 2. Histologically confirmed squamous cell carcinoma of the esophagus;
• • 3. Diagnosed with stage IVB disease (according to UICC TNM version 8);
• • 4. Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease was confirmed;
• • 5. Estimated life expectancy \>4 months;
• • 6. The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
• • 7. Ability to understand the study and sign informed consent.
• Exclusion Criteria:
• • 1. Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment;
• • 2. Patients with intracranial metastasis disease at diagnosis;
• • 3. History of thoracic irradiation;
• • 4. Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;
• • 5. Patients who have a preexisting esophagomediastinal fistula and/or esophagotracheal fistula;
• • 6. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
• • 7. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia.
• • 8. Inability to provide informed consent due to psychological, familial, social, and other factors;
• • 9. Female patients who are pregnant or during lactation;
• • 10. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
• • 11. A history of interstitial lung disease or non-infectious pneumonia;
• • 12. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).