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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463834
• Other study ID #: FujianCH1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: March 19, 2028

Study information

• Verified date: March 2024
• Source: Fujian Cancer Hospital
• Contact: Shuoyan Liu
• Phone: 138 0508 8816
• Email: shuoyanliu2010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 19, 2028
• Est. primary completion date: March 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

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