Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chemoradiotherapy （CRT）+sintilimab 1, CRT+sintilimab 2.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug chemoradiotherapy （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 - Drug CRT+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
Primary outcome measures
- progression free survival [Time frame: 1 years]
- Incidence rate of adverse events [Time frame: 3 years]
Secondary outcome measures (2)
- overall survival [Time frame: 3 years]
- Objective Response Rate [Time frame: 3 months after therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06468644 · ConES-ljc