PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Launched by SUN YAT-SEN UNIVERSITY · May 1, 2022

Keywords

ClinConnect Summary

The clinical trial called NEOCRTEC2101 is studying a new treatment approach for patients with locally advanced squamous cell esophageal cancer. Specifically, it aims to compare a combination of a PD-1 inhibitor (a type of cancer immunotherapy) with chemotherapy and radiation before surgery, against standard treatment of chemotherapy and radiation alone before surgery. The main goal is to see which method helps patients live longer after treatment.

To be eligible for this trial, participants need to be between 18 and 70 years old, have a specific stage of esophageal cancer that can be treated with surgery, and must not have received any previous cancer treatments. They also need to meet certain health criteria, such as having a good blood cell count and overall health. If someone joins the trial, they can expect to receive either the new combined treatment or the standard treatment, along with close monitoring by the medical team. This study is currently looking for volunteers, so if you or someone you know might fit these criteria, it could be a valuable opportunity to contribute to cancer research.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
• • 2. Patients must not have received any prior anticancer therapy.
• • 3. More than 6 months of expected survival.
• • 4. Age ranges from 18 to 70 years.
• • 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
• • 6. WHO PS score 0-1
• • 7. Signed informed consent document on file.
• Exclusion Criteria:
• • 1. Patients have received any prior anticancer therapy.
• • 2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
• • 3. Patients with concomitant hemorrhagic disease.
• • 4. Patients who cannot tolerate surgery.
• • 5. Pregnant or breast feeding.
• • 6. Patients without informed consent because of psychological, family, social or any other factors.
• • 7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
• • 8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
• • 9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
• • 10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
• • 11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
• • 12. Patients with history of interstitial lung disease or noninfectious pneumonia.
• • 13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
• • 14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).