Status:
ACTIVE_NOT_RECRUITING
Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic e...
Eligibility Criteria
Inclusion
- Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:
- Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);
- No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
- Expected to be achievable to conduct R0 resection.
- Patients must not enter this study if any of the following exclusion criteria is fulfilled:
- Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
- Combined with other inoperable condition;
- Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
- Combined with other conditions unsuitable for participation in this study as judged by investigators.
- Other protocol defined Inclusion/exclusion criteria could apply.
Exclusion
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2027
Estimated Enrollment :
663 Patients enrolled
Trial Details
Trial ID
NCT04848753
Start Date
June 23 2021
End Date
May 12 2027
Last Update
July 21 2023
Active Locations (48)
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1
The Firest Affiliated Hospital of bengbu Medical College
Bengbu, Anhui, China
2
Anhui provincial hospital
Hefei, Anhui, China, 230001
3
The Second Hospital of anhui Medical University
Hefei, Anhui, China
4
Jiangmen central Hospital
Jiangmen, Guangdong, China