Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma

NCT07430579 | Recruiting DMC

• 1 other identifier: Adebrelimab ZYP
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  pathological complete response，indicating that the cancer has been completely wiped out locally by the preoperative therapy, as confirmed under a microscope.

  the pathological evaluation at the end of Cycle 2-4 (each cycle is 21 days)

Secondary Outcomes (1)

• Major Pathological Response (MPR)

  the pathological evaluation at the end of Cycle 2-4 (each cycle is 21 days)

Study Arms (1)

adebrelimab combined with chemotherapy group

EXPERIMENTAL

In this study, all patients meeting the inclusion criteria received at least two cycles of neoadjuvant therapy with adebrelimab combined with chemotherapy, administered every 3 weeks per cycle according to the study protocol.

Procedure: adebrelimab combined with chemotherapy

Interventions

adebrelimab combined with chemotherapy PROCEDURE

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.

adebrelimab combined with chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histopathologically confirmed diagnosis of Esophageal Squamous Cell Carcinoma （ESCC）.
• Eligible patients are those with stage II/III disease according to the AJCC/UICC 8th edition Tumor-Node-Metastasis (TNM) staging system, presenting with cT1-3N1-2M0 or cT3-4aN0M0 disease.
• Patients could tolerate chemotherapy and surgery after evaluation and MDT discussion, accepting the clinical trial protocol.

You may not qualify if:

• Patients with a history of other uncured malignancies within the past 5 years, individuals with ongoing or a history of autoimmune diseases, and those who have received any prior anti-tumor therapy.
• Patients' cardio- pulmonary function could not tolerate surgery or chemotherapy, or don't accept the clinical trial protocol.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Qilu Hospital of Shandong University

Jinan, China

RECRUITING

MeSH Terms

Conditions

Pathologic Complete Response

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yunpeng Zhao, doctor

  The Second Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yunpeng Zhao, doctor

CONTACT

18766188692; zhaoyunpengsddx@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 24, 2026
• Study Start: December 9, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CN (1)