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Clinical Trials in China / NCT06463834
Recruiting Phase 2

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

NCT06463834 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Phase 2
Started
2024-03-20
Last updated
2024-06-18

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Sintilimab

Sintilimab: Sintilimab: 200mg, iv, D1, Q3W; DCF chemotherapy: docetaxel 70mg/m2,iv,d1,Q3W; cisplatin 75mg/m2,iv,d1,Q3W; 5-fluorouracil 750-800mg/m2,iv,d1-d5,Q3W

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06463834 on ClinicalTrials.gov ↗ ← All trials in China