Last updated: November 30, 2023
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Not Recruiting
Phase
3
Condition
Esophageal Disorders
Lung Cancer
Esophageal Cancer
Treatment
sintilimab
Clinical Study ID
NCT06161909
POSLS-union02
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed written informed consent prior to the implementation of any trial-relatedprocesses;
- 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 orPR (clinical staging of cT1b-T2,N+ or cT3-T4a,ANY N) (8th edition UICC/AJCC TNMstaging);
- Underwent radical surgery, and had negative surgical margins confirmed pathologicallyafter surgery (R0), defined as the absence of squamous carcinoma cells from theproximal, distal, or peripheral resection borders of esophageal carcinoma;
- Postoperative pathological assessment of non-pCR, and residual tumor in the primarytumor focus or regional lymph nodes.
Exclusion
Exclusion Criteria:
- Patients with an untreated diagnosis of another malignancy within 5 years prior to thefirst dose (excluding radically treated basal cell carcinoma of the skin, squamousepithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radicalresection);
- Serious surgical complications after resection of esophageal cancer with reference toClavien-Dindo classification > 3;
- Individuals with a history of allergy or hypersensitivity to components of the studydrug or severe hypersensitivity to any monoclonal antibody;
- All toxicities (other than nephropathy, neuropathy, hearing loss, alopecia, andfatigue) attributable to prior antitumor therapy (preoperative induction therapy) musthave recovered to baseline levels or Grade 1 (CTCAE Version 5.0) prior toadministration of study drug;
- Received systemic therapy with a proprietary medicine with an antitumor indication oran immunomodulatory drug (including thymidine, interferon, interleukin, except forlocal 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.
Study Design
Total Participants: 400
Treatment Group(s): 1
Primary Treatment: sintilimab
Phase: 3
Study Start date:
January 10, 2024
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
Fujian
Fujian, 350100
ChinaSite Not Available
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