A Phase 2/3 interventional study of TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab) in Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Qingdao Central Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Qingdao Central Hospital · Phase 2/3, Interventional, and Treatment
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.
657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.
This study's planned enrollment of 90 is above the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Qingdao Central Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
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A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours \< 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
Exclusion Criteria:
TP regimen plus PD-1 inhibitor for 4 cycles then irradiation and PD-1 inhibitor maintenance therapy for 13 cycles.
Drug: TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.
Overall survival (OS)
time from enrollment to patients death
Time frame: up to 24 months
Progression-free survival (PFS)
time from disease progression or patient death
Time frame: up to 12 months
overall response rate (ORR)
complete response plus partial response
Time frame: up to 12 weeks
toxicities
toxicities according to CTCAE 5.0
Time frame: up to 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Oct 2025, 25 months after the start.
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Esophageal Squamous Cell Carcinoma →
Qingdao Central Hospital