A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Phase 2

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma

• Registration Number: NCT06463834
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

Detailed Description

This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study Start: 2024-03-20
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-03-19
• Study Completion: 2028-03-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ≥18 years old and ≤75 years old
• Esophageal squamous cell carcinoma diagnosed biopsy histopathology
• The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
• At least one measurable lesion
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1
• With adequate organs function

Exclusion Criteria

• Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
• Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
• Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological complete response	4 weeks after surgery	Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Secondary Outcome Measures

Name	Time	Method
Major pathological response	4 weeks after surgery	Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Incidence rate of adverse events	3-year	The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Disease-free survival period	3-year	After surgery, there is no time for the disease to recur.

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China