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

NCT05659251 | Active Not Recruiting Phase 2

• 1 other identifier: 2022-1022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

Keywords

serplulimab; Esophageal Squamous Cell Carcinoma; Neoadjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR)

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

  1 month after surgery

Secondary Outcomes (6)

• major pathological response (MPR)

  1 month after surgery

• Objective Response Rate (ORR)

  before surgery

• 2-year and 5-year overall survival

  2-year and 5-year after surgery

• Incidence of Treatment-related Adverse Events

  1 month after surgery

• R0 resection rate

  1 month after surgery

Study Arms (1)

Serplulimab

EXPERIMENTAL

Preoperative neoadjuvant therapy for 3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Serplulimab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.

Combination Product: Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy; Procedure: Esophagectomy; Other: sample

Interventions

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.

Serplulimab

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.

Serplulimab

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.

Serplulimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009, China

Location

Related Publications (1)

• Wu Z, Wu C, Wang Y, Liang F, Qi L, Wang K, Shen G, Li J, Shen H, Wu M. Neoadjuvant serplulimab combined with chemotherapy for resectable oesophageal squamous cell carcinoma: a single-arm, phase 2 trial. Nat Commun. 2025 Dec 21. doi: 10.1038/s41467-025-67589-5. Online ahead of print.

  PMID: 41423619 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant Therapy; Esophagectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Weilin Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: December 1, 2022
• Primary Completion: October 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)