Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Pathological Complete Response (pCR) — the pathological evaluation at the end of Cycle 2-4 (each cycle is 21 days)
  pathological complete response，indicating that the cancer has been completely wiped out locally by the preoperative therapy, as confirmed under a microscope.

Trial sites (1)

More The Second Hospital of Shandong University trials in China

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