Trials / Active Not Recruiting
Active Not RecruitingNCT04848753
Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 663 (actual)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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 esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Toripalimab combined with cisplatin and paclitaxel | Specified doses on specified days. |
| COMBINATION_PRODUCT | Placebo combined with cisplatin and paclitaxel | Specified doses on specified days. |
Timeline
- Start date
- 2021-05-12
- Primary completion
- 2027-05-12
- Completion
- 2027-05-12
- First posted
- 2021-04-19
- Last updated
- 2026-04-08
Locations
48 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04848753. Inclusion in this directory is not an endorsement.