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

NCT05880082 | Completed Phase 2

• 1 other identifier: WGUO
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  From enrollment to the end of treatment at 4 weeks

  Up to approximately 6 months

• Major pathological response rate

  Pathological results were obtained after surgery

  At Surgery approximately 4weeks after last treatment

Secondary Outcomes (3)

• Pathological complete response rate

  At Surgery approximately 4weeks after last treatment

• Overall survival

  Up to 24 months

• Progression-free survival

  Up to 24 months

Study Arms (1)

tislelizumab, Q3W with TP regimen

EXPERIMENTAL

Tislelizumab 200mg, Q3W, 2-4 cycles Albumin paclitaxel 240 mg/m², adjusted according to the patient Carboplatin: AUC=5 Q3W, d1 or cisplatin: 20mg/m² iv, D1-3 Q3W or Nedaplatin: 70mg d1 Q3W

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Tislelizumab 200mg, Q3W, 2-4 cycles Albumin paclitaxel 240 mg/m², adjusted according to the patient Carboplatin: AUC=5 Q3W, d1 or cisplatin: 20mg/m² iv, D1-3 Q3W or Nedaplatin: 70mg d1 Q3W

Also known as: Carboplatin, cisplatin, Nedaplatin

tislelizumab, Q3W with TP regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.);
• 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;
• 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;
• Other conditions that the researchers believe will affect the progress of the study.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumab; Carboplatin; Cisplatin; nedaplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The study was a one-arm open study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 30, 2023
• Study Start: January 13, 2023
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)