Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 60
- Primary Endpoint
- progression free survival
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old
- •Histopathological examination of the primary biopsy confirmed the diagnosis of locally 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 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
Arms & Interventions
Group A
dose 1 of radiotherapy+sintilimab
Intervention: chemoradiotherapy （CRT）+sintilimab 1 (Drug)
Group B
dose 2 of radiotherapy+sintilimab
Intervention: CRT+sintilimab 2 (Drug)
Outcomes
Primary Outcomes
progression free survival
Time Frame: 1 years
the time from random assignment in a clinical trial to disease progression or death from any cause
Incidence rate of adverse events
Time Frame: 3 years
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Secondary Outcomes
- overall survival(3 years)
- Objective Response Rate(3 months after therapy)