Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma
- Conditions
- Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy
- Interventions
- Registration Number
- NCT03829969
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
This is one randomized, double-blind, multi-center, placebo-controlled phase III study. The objective of this study is to compare the effectiveness and safety of JS001 combined with paclitaxel and cisplatin(TP regimen )with placebo combined with TP regimen in patients with advanced or metastatic Esophageal Squamous Cell Carcinoma(ESCC )who have not received systemic chemotherapy previously.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Toripalimab Toripalimab Toripalimab combine with paclitaxel and cisplatin placebo Toripalimab Placebo combine with paclitaxel and cisplatin
- Primary Outcome Measures
Name Time Method OS (Overall Survival) up to 2 years To evaluate the differences in OS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria)
PFS((Progression-Free Surviv) PFS: up to 2years To evaluate the differences in PFS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria).
- Secondary Outcome Measures
Name Time Method OS Rate up to 2 years 2 years OS rate
PFS Rate:BICR Up to 1 years 1 years PFS rate
DOR(Duration of Response: Recist 1.1,BICR ) Up to 2 approximately years To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed duration of response (DoR) according to RECIST v1.1 DOR is defined as the time from first documented response to first documented evidence of disease progression or to death, whichever comes first.
TTR(Time to Initial Response:BICR ) Up to 2 approximately years To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed Time to initial Response (TTR) according to RECIST v1.1 TTR is defined as the time from randomization to the first recorded response (CR or PR).
PFS Up to 2 approximately years To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy，as measured by investigator-assessed progression free survival (PFS) according to RECIST v1.1
ORR(Overall Response Rate:BICR) Up to 2 approximately years To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed overall response rate (ORR), daccording to RECIST v1.1; ORR:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
DCR(Disease Control Rate:BICR ) Up to 2 approximately years To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed disease control rate (DCR) according to RECIST v1.1 DCR is defined as the proportion of patients with the best efficacy of CR or PR or SD.
DoR Assessed Per irRECIST:BICR From date of response until progressive disease. Up to 2 approximately years To evaluate DOR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST
TTR Assessed Per irRECIST:BICR From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate TTR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST
Patient-Reported Outcomes Collected Via the EORTC QLQ-C30 From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate the quality of life (QoL) following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized population.
PFS Assessed Per irRECIST From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST
ORR Assessed Per irRECIST From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST
DCR Assessed Per irRECIST From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST
Patient-Reported Outcomes Collected Via the EORTC QLQ-OES18 From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years To evaluate the quality of life (QoL) following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized population.
Trial Locations
- Locations (1)
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China