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

NCT ID: NCT05659251

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Serplulimab

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: COMBINATION_PRODUCT

Esophagectomy

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.

Intervention Type: PROCEDURE

sample

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. signed informed consent;

2. patients age 18 to 75 years old

3. primary resectable, histologically confirmed esophageal squamous cell cancer;

4. Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).

5. ECOG PS 0-1.

6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;

Exclusion Criteria

1. with significant cardiovascular disease;

2. current treatment with anti-viral therapy or HBV;

3. Female patients who are pregnant or lactating;

4. history of malignancy within 5 years prior to screening;

5. active or history of autoimmune disease or immune deficiency;

6. signs of distant metastases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weilin Wang

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, China

Countries

China

Other Identifiers

2022-1022

Identifier Type: -

Identifier Source: org_study_id