Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment options for patients with advanced esophageal squamous cell carcinoma, a type of cancer that affects the throat. The researchers want to see if combining a medication called Camrelizumab (which helps boost the immune system) with chemotherapy is more effective than the traditional approach of using both chemotherapy and radiation therapy. The goal is to find better ways to treat patients whose cancer cannot initially be surgically removed, helping them potentially become eligible for surgery later on.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed diagnosis of squamous cell carcinoma located in the thoracic esophagus. They should not have received any prior treatments like chemotherapy or radiation for their cancer. Participants will undergo evaluations to ensure they are healthy enough for the trial and will need to provide written consent. This study is not yet recruiting participants, but it aims to contribute valuable information to improve treatment guidelines for esophageal cancer.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • histologically-confirmed squamous cell carcinoma
• • primary lesions located in the thoracic esophagus
• • clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes
• • having not received neoadjuvant therapy
• • 18-75 years
• • ECOG performance status of 0 or 1
• • no prior chemotherapy, radiotherapy, or immunotherapy for any cancers
• • adequate organ function
• • expectation of R0 resection
• • provision of written informed consent.
• Exclusion Criteria:
• • corticosteroid treatment (equivalent to prednisone \>10 mg/day) within 14 days before the first day of the drug administration
• • acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections
• • history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans
• • known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment
• • physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications
• • comorbidities, including chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, and unstable mental disorders requiring therapy
• • allergy to drugs used in the study
• • participation in other clinical trials within 30 days before enrollment
• • ineligibility for participation based on the decision of investigators.