Advanced Esophageal Cancer
Conditions
Keywords
PD-1Antibody, advanced esophageal cancer, paclitaxel, cisplatin
Brief summary
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. 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. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
Interventions
DRUGSHR-1210
SHR-1210 200mg
DRUGPlacebo
Placebo
DRUGpaclitaxel
paclitaxel 175mg/m2
DRUGcisplatin
cisplatin 75mg/m2
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. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma; 2. No previous systemic anti-tumor treatment; 3. Subjects must have at least one measurable tumor lesion per RECIST 1.1; 4. Tissue samples should be provided for biomarkers (such as PD-L1) analysis; 5. ECOG: 0-1; 6. Adequate organ and bone marrow function;
Exclusion criteria
1. Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs; 2. Prior therapy as follow: 1. Anti-PD-1 or anti-PD-L1; 2. Any experimental drugs within 4 weeks of the first dose of study medication; 3. Received major operations or serious injuries within 4 weeks of the first dose of study medication; 4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication; 3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment; 4. Subjects with any active autoimmune disease or history of autoimmune disease; 5. Pregnancy or breast feeding;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by IRC | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| OS | approximately 22 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 and 9 month OS rate | approximately 6 and 9 months | 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 | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| DCR | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| DoR | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| AE | approximately 22 months | adverse events |
| PFS assessed by investigators | approximately 22 months | based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Antidrug Antibodies (ADAs) | approximately 22 months | To evaluate the incidence of ADAs against SHR-1210 |
Countries
China
Outcome results
None listed