The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multicenter, randomized, double-blind, open-label phase II clinical trial of anti-PD-1 antibody SHR-1210 versus placebo as consolidation chemotherapy (CCT) after radical concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (ESCC).The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
725
First stage: Concurrent chemoradiotherapy: Cisplatin:25-30mg/m2 ivgtt d1;Capecitabine:800mg/m2, bid d1-5,qw,5weeks;Synchronous radiotherapy:1.8-2Gy/d,5d/W,45-50Gy。 Consolidation treatment: Cisplatin: 60-75mg/m2 ivgtt d1 Capecitabine:1000mg/m2, bid d1-14,q3w 6weeks。 Second stage: SHR-1210 was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight \<50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.
First stage: Concurrent chemoradiotherapy: Cisplatin:25-30mg/m2 ivgtt d1;Capecitabine:800mg/m2, bid d1-5,qw,5weeks;Synchronous radiotherapy:1.8-2Gy/d,5d/W,45-50Gy。 Consolidation treatment: Cisplatin: 60-75mg/m2 ivgtt d1 Capecitabine:1000mg/m2, bid d1-14,q3w 6weeks。 Second stage: Placebo was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight \<50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
PFS
Evaluation of anti-PD-1 antibody SHR-1210 for progression-free survival in patients with locally advanced esophageal squamous cell carcinoma who did not develop disease after concurrent chemoradiotherapy
Time frame: up to 2 year
OS
From date of randomization until the date of death from any cause
Time frame: up to 2 year
ORR
Evaluation of the objective response rate of anti-PD-1 antibody SHR-1210 versus placebo in patients with locally advanced esophageal squamous cell carcinoma who had no disease progression after concurrent chemoradiotherapy(RECIST 1.1)
Time frame: up to 2 year
DOR
defined as the time from the first determination of an objective response until the first documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes first
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30).
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18).
Time frame: up to 2 year
Health-Related Quality of Life (HRQoL)
assessment of the patient's overall health status using the generic health state instrument European Quality of Life- 5 Dimensions (EuroQol 5D EQ-5D-5L).
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Time frame: up to 2 year
The incidence and severity of adverse events (AEs)
according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
Time frame: up to 2 year