Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced esophageal squamous cell carcinoma, specifically those whose cancer cannot be surgically removed or has returned after surgery. The trial combines traditional treatments like chemotherapy and radiation therapy with a newer type of treatment called immunotherapy, which helps the body’s immune system fight cancer. Researchers are looking to see how effective this combination is and how well patients tolerate the treatment.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of esophageal squamous cell carcinoma that hasn't been treated with radiation before. They should also be in relatively good health, with specific lab results showing their blood counts and liver function meet certain criteria. Participants will receive treatment over several weeks and will have regular check-ups to monitor their response to the therapy and any side effects. This study is currently recruiting, and it could be an important opportunity for those looking for new treatment options for this challenging condition.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years old, gender unlimited
• • 2. Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
• • 3. According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
• • 4. ECOG: 0\~1
• • 5. Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN
• • 7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
• Exclusion Criteria:
• • 1. Other malignant tumors have been diagnosed within the previous 5 years
• • 2. There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
• • 3. Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
• • 4. Have any history of active autoimmune disease or autoimmune disease
• • 5. Have clinical symptoms or diseases of the heart that are not under control
• • 6. Active infection or fever (except definite tumor fever)
• • 7. History or evidence of interstitial lung disease or active non-infectious pneumonia
• • 8. Patients with immune dysfunction and active hepatitis
• • 9. Those who have previously received PD-1 or PD-L1 antibody therapy
• • 10. Allergic to any drug in this protocol
• • 11. Patients receiving immunosuppressive drugs or corticosteroids \>10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
• • 12. Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
• • 13. Pregnant or lactating women