PPIO-004 Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Technology in Neoadjuvant Immunotherapy for Esophageal Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Treatments: Carboplatin; Cisplatin; Nedaplatin; Tislelizumab

Criteria

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.