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

Phase 2

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

• Registration Number: NCT05659251
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. signed informed consent;<br><br> 2. patients age 18 to 75 years old<br><br> 3. primary resectable, histologically confirmed esophageal squamous cell cancer;<br><br> 4. Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC<br> TNM stage, 8th edition).<br><br> 5. ECOG PS 0-1.<br><br> 6. No distant metastasis, the diseases could be resectable assessed by thoracic<br> oncologist;<br><br>Exclusion Criteria:<br><br> 1. with significant cardiovascular disease;<br><br> 2. current treatment with anti-viral therapy or HBV;<br><br> 3. Female patients who are pregnant or lactating;<br><br> 4. history of malignancy within 5 years prior to screening;<br><br> 5. active or history of autoimmune disease or immune deficiency;<br><br> 6. signs of distant metastases.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (PCR)

Secondary Outcome Measures

Name	Time	Method
major pathological response (MPR);Objective Response Rate (ORR);2-year and 5-year overall survival;Incidence of Treatment-related Adverse Events;R0 resection rate;The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients