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

NCT06468670 | Not Yet Recruiting Phase 2

• 1 other identifier: NeoES-ljc
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• overall survival

  3 years

• Disease-free survival

  3 years

Study Arms (1)

short-course radiotherapy+sintilimab

EXPERIMENTAL

Drug: sintilimab，programmed death 1 monoclonal antibody

Interventions

sintilimab，programmed death 1 monoclonal antibody DRUG

short-course radiotherapy +sintilimab (200mg, iv, D1, Q3W)

short-course radiotherapy+sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Jiancheng Li

CONTACT

86-13906900190; jianchengli6@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: June 17, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share