Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468670
• Other study ID #: NeoES-ljc
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 17, 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Fujian Cancer Hospital
• Contact: Jiancheng Li
• Phone: 86-13906900190
• Email: jianchengli6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.

Description:

This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2027
• Est. primary completion date: June 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

• Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+

• 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,programmed death 1 monoclonal antibody
short-course radiotherapy +sintilimab (200mg, iv, D1, Q3W)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

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
Primary	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 years
Secondary	overall survival	the time from randomization to death	3 years
Secondary	Disease-free survival	the time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment	3 years