Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

Launched by SHANGHAI CHEST HOSPITAL · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called SCR-ESCC-02, is exploring a new treatment approach for patients with locally advanced esophageal cancer that cannot be surgically removed. The study aims to combine immunotherapy (a treatment that helps your immune system fight cancer) with chemotherapy and radiation therapy to see how safe and effective this combination is. Researchers are looking for individuals between the ages of 18 and 75 who have not received any prior cancer treatments and meet specific health criteria.

If you or a loved one are considering participation, you'll need to be healthy enough to handle the treatment and willing to use contraception during the study. Participants will receive a combination of medications and therapies over a set period, and the team will monitor their health closely throughout the trial. This is a great opportunity to help advance cancer treatment while potentially benefiting from new therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years.
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• • 3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
• • 4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
• • 5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
• • 6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
• • 7. Willingness to use contraception with an adequate method throughout the study.
• • 8. Documented informed consent.
• Exclusion Criteria:
• • 1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
• • 2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
• • 3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
• • 4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
• 5. Presence of any severe or uncontrolled coexisting diseases, including but not limited to:
• • Uncontrolled hypertension
• • History of interstitial lung disease or non-infectious pneumonia
• • Active hepatitis B or C, syphilis, or other active and uncontrolled infections
• • Cardiac insufficiency (NYHA≥2)
• • Renal dysfunction requiring dialysis
• • Active autoimmune disease
• • History of acquired or congenital immunodeficiency diseases
• • 6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
• • 7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
• • 8. Allergy to study drugs.
• • 9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.