Esophageal Cancer Clinical Trials

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Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent

• Aged 18 years or above

• Histologically confirmed esophageal squamous cell carcinoma

• Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification

⁃ 7\. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Kuaile Zhao, MD
kuaile_z@sina.com
+86-21-64175590
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2031-02
Participants
Target number of participants: 452
Treatments
Experimental: CCRT and PD-1 inhibitor maintenance therapy
Radiotherapy: 50.4Gy/28Fx. Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d~PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year within 42 days after the end of radiotherapy
Active_comparator: CCRT and surveillance
Radiotherapy: 50.4Gy/28Fx. Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov