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

NCT ID: NCT06468670

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2027-06-30

Brief 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.

Detailed 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).

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short-course radiotherapy+sintilimab

Group Type: EXPERIMENTAL

sintilimab，programmed death 1 monoclonal antibody

Intervention Type: DRUG

short-course radiotherapy

+sintilimab (200mg, iv, D1, Q3W)

Interventions

sintilimab，programmed death 1 monoclonal antibody

short-course radiotherapy

+sintilimab (200mg, iv, D1, Q3W)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jiancheng Li

Role: CONTACT

jianchengli6@126.com

86-13906900190

Other Identifiers

NeoES-ljc

Identifier Type: -

Identifier Source: org_study_id