Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Local… (NCT07549100) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
China30 participantsStarted 2023-05-15
Plain-language summary
This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.
Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Written informed consent is obtained prior to any study-related procedures.
✓. Age 18 to 75 years, inclusive; both male and female patients are eligible.
✓. Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:
✓. No evidence of distant metastasis.
✓. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Estimated life expectancy of ≥6 months.
✓. Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment):
Exclusion criteria
✕. Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.
What they're measuring
1
Conversion Surgery Rate
Timeframe: Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles
✕. Evidence of distant metastasis confirmed by imaging.
✕. History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
✕. Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.
✕. Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.
✕. Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible.
✕. Patients with asthma requiring bronchodilator therapy are not eligible.
✕. Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.