Esophageal Cancer
Conditions
Keywords
PD-1Antibody, locally advanced esophageal cancer
Brief summary
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed description
In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
Interventions
RADIATIONRadiation
Concurrent Radiation
DRUGCisplatin
IV infusion
DRUGPlacebo
IV infusion
DRUGCamrelizumab
IV infusion
DRUGPaclitaxel
IV infusion
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
Exclusion criteria
1. Indicators of severe malnutrition; 2. A history of surgery for esophageal cancer; 3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention; 4. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy; 5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies; 6. Active autoimmune diseases or history of autoimmune diseases that may relapse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by IRC | up to 3 years | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by investigators | up to 3 years | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| OS | up to 3 years | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier. |
| ORR | up to 3 years | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| DoR | up to 3 years | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| AE | up to 3 years | adverse events |
Countries
China
Outcome results
None listed