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

Phase 2

Not yet recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: sintilimab，programmed death 1 monoclonal antibody

• Registration Number: NCT06468670
• Lead Sponsor: Fujian Cancer Hospital

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).

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-17
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
short-course radiotherapy+sintilimab	sintilimab，programmed death 1 monoclonal antibody	-

Primary Outcome Measures

Name	Time	Method
Pathological complete response	4 weeks after surgery	Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Incidence rate of adverse events	3 years	The ratio of the number of cases with adverse events to the total number of cases available for evaluation.

Secondary Outcome Measures

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