Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGchemoradiotherapy （CRT）+sintilimab 1
radiotherapy (50.4Gy/1.8Gy/28f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W
DRUGCRT+sintilimab 2
radiotherapy (60Gy/2Gy/30f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 1 years | the time from random assignment in a clinical trial to disease progression or death from any cause |
| 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | the time from randomization to death |
| Objective Response Rate | 3 months after therapy | the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors 1.1 |
Contacts
Primary ContactJiancheng Li
Outcome results
None listed