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 range18 Years
SexALL
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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;
✕. 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.);
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
✕. 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);