Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma

Last updated: June 17, 2024
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Squamous Cell Carcinoma

Carcinoma

Lung Cancer

Treatment

CRT+sintilimab 2

chemoradiotherapy (CRT)+sintilimab 1

Clinical Study ID

NCT06468644
ConES-ljc
  • Ages > 18
  • All Genders

Study Summary

This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old

  • Histopathological examination of the primary biopsy confirmed the diagnosis oflocally advanced esophageal squamous cell carcinoma

  • At least one measurable lesion

  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1

  • With adequate organs function

Exclusion

Exclusion Criteria:

  • Patients with active malignancy within 5 years other than the tumor studied in thisstudy or a localized tumor that has been cured such as resected basal or squamouscell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breastcancer

  • Patients who have a higher risk of bleeding or perforation due to the tumor'sobvious 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 thepast, including radiotherapy, chemotherapy, immunotherapy (including but not limitedto interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: CRT+sintilimab 2
Phase: 2
Study Start date:
June 17, 2024
Estimated Completion Date:
June 30, 2027

Study Description

This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.