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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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

Locations (1)

Fujian Cancer Hospital
Fuzhou, Fujian, China