Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for patients with a type of esophagus cancer called unresectable esophageal squamous cell carcinoma (ESCC). This means that the cancer is advanced and cannot be surgically removed. The trial aims to understand how effective different combination therapies are, which include chemotherapy, radiation, and a type of immunotherapy called Tislelizumab. Researchers will look at several important factors, such as how many patients can have their tumors surgically removed after treatment, how well they tolerate the treatments, and the overall survival rates for patients one year after treatment.

To be eligible for this trial, participants need to have a confirmed diagnosis of ESCC, have not received any prior cancer treatments, and meet certain health criteria. For example, they should have a good performance status, meaning they can carry out daily activities without much difficulty. If someone joins the trial, they will receive treatment and be closely monitored for their health and progress. This study hopes to provide valuable information that could improve treatment options for patients with this challenging type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed sorely ESCC without other histology subtypes.
• • 2. Thoracic esophageal cancer.
• • 3. No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
• • 4. Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI).
• • 5. The Karnofsky Performance Scale (KPS) ≥70.
• • 6. Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\*9/L; neutrophil count (NEUT) ≥ 1.5×10\*9/L; platelets (PLT) ≥ 100×10\*9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL.
• Exclusion Criteria:
• • 1. Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• • 2. Patients have undergone any type of anti-cancer treatment.
• • 3. Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases.
• • 4. Investigators assessed major vessel involvement with high-risk hemorrhage.
• • 5. A higher probability of esophageal perforation during conversion therapy.
• • 6. Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus.
• • 7. Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents.
• • 8. Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery.
• • 9. Pregnant or lactating women and women of childbearing potential who lacked effective contraception.
• • 10. Non-compliance with the inclusion criteria judged by investigators.