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NCT Number: NCT05659251

Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • ECOG PS 0-1.
  • 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.

Treatment and study plan

Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy

Combination Product

Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days.

Esophagectomy

Procedure

Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy.

The surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon.

Sample

Other

Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use.

5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery.

Tumour sample will be collected before neoadjuvant therapy and after surgery.

Primary outcomes

  1. 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

  1. major pathological response (MPR)

    Time frame: 1 month after surgery

    In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.

  2. Objective Response Rate (ORR)

    Time frame: before surgery

    The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria

  3. 2-year and 5-year overall survival

    Time frame: 2-year and 5-year after surgery

    The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery

  4. Incidence of Treatment-related Adverse Events

    Time frame: 1 month after surgery

    Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0

  5. R0 resection rate

    Time frame: 1 month after surgery

    The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope

  6. The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients

    Time frame: 3 months after surgery

    By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the peripheral blood and tumor sample of ESCC patients before and after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Dec 21, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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