Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Technology in Neoadjuvant Immunotherapy for Esophageal Cancer

WGUO

The goal of this observational study is to learn about in potential operable esophageal cancer patients (cT1-2N + M0 and cT3NanyM0) receiving neoadjuvant therapy. The main questions it aims to answer are: Objective response rate, Major pathological response rate. Participants will receive two to four cycles of tislelizumab plus albuminpaclitaxel and platinum-based therapy

2023-04-13

2024-02-01

2024-12-31

Early phase I

62

Inclusion Criteria: 1. ≥18 years old; 2. Pathology (histology) confirmed potentially resectable stage cT1-2N + M0 and stage cT3NanyM0 ESCC (AJCC 8th edition); 3. Received tirelizumab combined with chemotherapy before surgery; 4.ECOG score: 0 or 1; 5. R0 radical excision can be performed; 6. Measurable or evaluable lesions assessed by the investigator according to RECIST version 1.1; 7. With my consent and signed informed consent, I shall comply with the planned visit, research treatment, laboratory examination and other test procedures. Exclusion Criteria: 1. Patients with other malignant tumors; 2. Prior treatment for ESCC, including chemotherapy, radiotherapy, or prior antibody or drug therapy against PD-1, anti-PD-L1, anti-PD-L2, or any other specific T-cell costimulation or checkpoint pathway; 3. They are not eligible to receive platinum-containing double-drug chemotherapy regimen, chemoradiotherapy or surgery; 4. Patients with a history of fistulas caused by primary tumor infiltration, patients assessed by the investigator as being at high risk of fistulas or showing signs of perforation, and severe malnutrition; 5. Poorly controlled pleural effusion, pericardial effusion or ascites requiring frequent drainage (recurrence within 2 weeks after intervention) 6. Known human immunodeficiency virus (HIV) testing history or known acquired immunodeficiency syndrome (AIDS); 7. A history of interstitial lung disease, non-infectious pneumonia or poorly controlled lung disease (including pulmonary fibrosis, acute lung disease, etc.); 8. Any positive test result for hepatitis B virus or hepatitis C virus indicating the presence of a virus, such as hepatitis B surface antigen (HBsAg, Australian antigen) positive or hepatitis C antibody (anti-HCV) positive (except HCV-RNA negative); 9. Those who have a history of drug abuse and cannot abstain or have mental disorders; 10. Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation; 11. Patients who are participating in other clinical trials or participating in other clinical trials with less than 4 weeks to end; 12. Pregnant or lactating women; 13. Patients with a BMI \< 18.5mg/m2 or a weight loss greater than 10% before screening; 14. Other conditions that the researchers believe will affect the progress of the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study was a one-arm open study'}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

2024-01-11