Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in … (NCT05461794) | Clinical Trial Compass
TerminatedPhase 2
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Stopped: Due to modification of company strategy.
China96 participantsStarted 2022-10-03
Plain-language summary
The study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who experienced disease progression following prior systemic chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent
✓. At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by local site investigator/radiology assessment ≤ 28 days before randomization Note: Lesions that had been previously irradiated were considered evaluable provided
✓. Eastern Cooperative Oncology Group (ECOG) score ≤ 1
✓. Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization
Exclusion criteria
✕. Have any contraindication for receiving treatment with both docetaxel and irinotecan
✕. Participants with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels)
✕. Participants with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator
What they're measuring
1
Arms A and C: Overall Response Rate (ORR)
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
✕. History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization
✕. Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, receptor tyrosine kinases (RTKs) with a similar target profile or Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth Factor Receptor-targeted (VEGFR) monoclonal antibodies)