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NCT05880082CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
118 (actual)
First submitted
17 May 2023
Start date
13 Jan 2023
Primary completion date
18 Aug 2025
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
NCT number
NCT05880082

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 118
  • From 13 Jan 2023 to the primary completion date, 18 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • They are not eligible to receive platinum-containing double-drug chemotherapy regimen, chemoradiotherapy or surgery;

Other illness

  • Patients with other malignant tumors;
  • 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;
  • Known human immunodeficiency virus (HIV) testing history or known acquired immunodeficiency syndrome (AIDS);
  • A history of interstitial lung disease, non-infectious pneumonia or poorly controlled lung disease (including pulmonary fibrosis, acute lung disease, etc.);
  • 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);
  • Those who have a history of drug abuse and cannot abstain or have mental disorders;
  • Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation;
  • Other conditions that the researchers believe will affect the progress of the study.

Other

  • Poorly controlled pleural effusion, pericardial effusion or ascites requiring frequent drainage (recurrence within 2 weeks after intervention)
  • Patients who are participating in other clinical trials or participating in other clinical trials with less than 4 weeks to end;
  • Pregnant or lactating women;
  • Patients with a BMI \< 18.5mg/m2 or a weight loss greater than 10% before screening;

Who the study is looking for

  • ≥18 years old;
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Army Medical Center of the People's Liberation Army
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.