Status:
NOT_YET_RECRUITING
Postoperative Immune Maintenance Therapy for Esophageal Squamous Cell Carcinoma After Radical Resection
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Esophageal Squamous Cell Carcinoma Thoracic Stage II
Esophageal Squamous Cell Carcinoma Thoracic Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Esophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the ...
Detailed Description
sophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the l...
Eligibility Criteria
Inclusion
- Signed written informed consent prior to the implementation of any trial-related processes;
- Male or female, ≥18 years of age or ≤75 years of age;
- Pathologically confirmed ESCC in the thoracic segment;
- Received 2-4 cycles of neoadjuvant chemoimmunotherapy and assessed by imaging as CR or PR (clinical staging of cT1b-T2,N+ or cT3-T4a,ANY N) (8th edition UICC/AJCC TNM staging);
- Underwent radical surgery, and had negative surgical margins confirmed pathologically after surgery (R0), defined as the absence of squamous carcinoma cells from the proximal, distal, or peripheral resection borders of esophageal carcinoma;
- Postoperative pathological assessment of non-pCR, and residual tumor in the primary tumor focus or regional lymph nodes.
Exclusion
- Patients with an untreated diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection);
- Serious surgical complications after resection of esophageal cancer with reference to Clavien-Dindo classification \> 3;
- Individuals with a history of allergy or hypersensitivity to components of the study drug or severe hypersensitivity to any monoclonal antibody;
- All toxicities (other than nephropathy, neuropathy, hearing loss, alopecia, and fatigue) attributable to prior antitumor therapy (preoperative induction therapy) must have recovered to baseline levels or Grade 1 (CTCAE Version 5.0) prior to administration of study drug;
- Received systemic therapy with a proprietary medicine with an antitumor indication or an immunomodulatory drug (including thymidine, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks prior to the first dose;
- Women who are pregnant or breastfeeding;
- Presence of any serious or uncontrollable systemic disease.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06161909
Start Date
January 10 2024
End Date
February 1 2026
Last Update
December 8 2023
Active Locations (1)
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1
Fujian
Fujian, China, 350100