MedTrace Logo

Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma

NCT07430579 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-02-24

No results posted yet for this study

Summary

This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant therapy with adebrelimab combined with platinum-based chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) at the Second Qilu Hospital of Shandong University.

The primary endpoint of this clinical trial is the pathological complete response (pCR) rate, defined as the absence of residual viable tumor cells in the resected specimen, including lymph nodes (ypT0N0M0). Secondary endpoints include the major pathological response (MPR) rate, objective response rate (ORR), treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs), as well as quality of life (QOL) assessments during neoadjuvant immunochemotherapy (nICT). MPR is defined as less than 10% residual viable tumor cells in the primary tumor bed following neoadjuvant therapy and resection. ORR represents the percentage of patients achieving complete response (CR) or partial response (PR). Other secondary measures include the tumor downstaging rate, surgery rate, R0 resection rate (defined as no residual tumor at the resection margins), and perioperative complication rate. Furthermore, overall survival (OS) and relapse-free survival (RFS) are considered exploratory endpoints in this study. By evaluating these diverse endpoints, the investigators aim to comprehensively assess the efficacy, safety, and overall impact of the nICT approach in patients with locally advanced resectable ESCC. Additionally, it is planned to construct 20 pairs of esophageal squamous cell carcinoma and adjacent normal esophageal squamous epithelial organoids, laying the groundwork for future in-depth exploration of the mechanisms underlying esophageal carcinogenesis and progression, as well as functional studies of specific genes.

Conditions

  • Pathological Complete Remission
  • Objective Response Rate
  • Immune-related Adverse Events
  • Quality of Life

Interventions

PROCEDURE

adebrelimab combined with chemotherapy

The treatment regimen consisted of adebrelimab combined with chemotherapy, administered every 3 weeks per cycle according to the study protocol. The specific treatment regimen was as follows: Adebrelimab: 20 mg/kg, intravenous infusion on day 1 of each 3-week cycle; Cisplatin: 75 mg/m², intravenous injection on day 2 of each cycle, or Carboplatin: area under the curve (AUC) 5, intravenous injection on day 2 of each cycle; Liposomal paclitaxel: 175 mg/m², intravenous injection on day 2 of each cycle, or Nab-paclitaxel: 260 mg/m², intravenous infusion over 30 minutes on day 2 of each cycle.

Sponsors & Collaborators

  • The Second Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yunpeng Zhao, doctor · The Second Qilu Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430579 on ClinicalTrials.gov