PPIO-004 Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Techno… (NCT05880082) | Clinical Trial Compass
CompletedPhase 2
PPIO-004 Clinical Application of Efficacy Prediction Model Based on Epigenomics Sequencing Technology in Neoadjuvant Immunotherapy for Esophageal Cancer
China118 participantsStarted 2023-01-13
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥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.
Exclusion criteria
. Patients with other malignant tumors;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: Up to approximately 6 months
2
Major pathological response rate
Timeframe: At Surgery approximately 4weeks after last treatment
Trial details
NCT IDNCT05880082
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
. They are not eligible to receive platinum-containing double-drug chemotherapy regimen, chemoradiotherapy or surgery;
. 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;
. Poorly controlled pleural effusion, pericardial effusion or ascites requiring frequent drainage (recurrence within 2 weeks after intervention)
. 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);