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Clinical Trials/NCT05659251
NCT05659251Active, not recruitingPhase 2

A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

Second Affiliated Hospital, School of Medicine, Zhejiang University2 sites in 1 country48 target enrollmentStarted: December 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Enrollment
48
Locations
2
Primary Endpoint
Pathological Complete Response (PCR)

Study Overview

Brief Summary

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • signed informed consent;
  • patients age 18 to 75 years old
  • primary resectable, histologically confirmed esophageal squamous cell cancer;
  • Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
  • No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;

Exclusion Criteria

  • with significant cardiovascular disease;
  • current treatment with anti-viral therapy or HBV;
  • Female patients who are pregnant or lactating;
  • history of malignancy within 5 years prior to screening;
  • active or history of autoimmune disease or immune deficiency;
  • signs of distant metastases.

Outcomes

Primary Outcomes

Pathological Complete Response (PCR)

Time Frame: 1 month after surgery

No residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes.

Secondary Outcomes

  • Objective Response Rate (ORR)(before surgery)
  • major pathological response (MPR)(1 month after surgery)
  • 2-year and 5-year overall survival(2-year and 5-year after surgery)
  • R0 resection rate(1 month after surgery)
  • Incidence of Treatment-related Adverse Events(1 month after surgery)
  • The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients(3 months after surgery)

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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