Patterns of recurrence after surgery alone versus preoperative chemoradiotherapy and surgery in the CROSS trials.
Vera Oppedijk, Ate van der Gaast, Jan J B van Lanschot...
https://pubmed.ncbi.nlm.nih.gov/24419108/Actively Recruiting
Led by Guo Xufeng · Updated on 2023-09-28
73
Participants Needed
1
Research Sites
117 weeks
Total Duration
Researchers are studying patients with thoracic esophageal squamous cell carcinoma who receive neoadjuvant immunotherapy combined with chemotherapy followed by surgical removal of the tumor. The purpose is to assess whether adding further adjuvant therapy after surgery improves survival outcomes. This phase II study focuses on patients with specific clinical stages of esophageal cancer based on established cancer staging criteria. Eligible patients receive two cycles of neoadjuvant treatment with tislelizumab 200 mg every 3 weeks and chemotherapy drugs nad-paclitaxel and carboplatin. After surgery with complete tumor removal R0 resection, patients with no pathological residual cancer pCR receive tislelizumab for up to 30 weeks, while those without pCR receive two cycles of adjuvant immunotherapy plus chemotherapy followed by tislelizumab for 24 weeks. This approach evaluates the impact of additional therapy based on surgical response. Participants undergo regular assessments including imaging, pathological evaluation four weeks after surgery, and long-term follow-up for up to five years. Researchers monitor disease-free survival, overall survival, tumor response rates, surgical success, and adverse events. The main outcome is two-year disease-free survival among patients without complete response. Safety and effectiveness measures continue throughout the study and extended observation periods.
CONDITIONS
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
X
Xufeng Guo, PH.D
X
Xufeng Guo, Ph.D
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Guo Xufeng
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks (2 cycles every 3 weeks)
Participants receive neoadjuvant immunotherapy with tislelizumab combined with chemotherapy before surgery.
2 visits (in-person) every 3 weeks
Duration - 1 day (surgery day)
Participants undergo surgery for tumor removal following neoadjuvant treatment.
1 visit (in-person)
Duration - Up to 30 weeks of tislelizumab treatment, plus 2 cycles of chemotherapy if non-pCR
After surgery, participants receive adjuvant immunotherapy with tislelizumab, with or without chemotherapy depending on tumor response.
Visits every 3 weeks during treatment, total duration up to 30 weeks
Duration - Up to 5 years
Participants are monitored for disease-free survival and overall health after completion of adjuvant treatment.
Periodic visits for assessments up to 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Vera Oppedijk, Ate van der Gaast, Jan J B van Lanschot...
https://pubmed.ncbi.nlm.nih.gov/24419108/Ronan J Kelly, Jaffer A Ajani, Jaroslaw Kuzdzal...
https://pubmed.ncbi.nlm.nih.gov/33789008/Hong Yang, Hui Liu, Yuping Chen...
https://pubmed.ncbi.nlm.nih.gov/34160577/Guo Xufeng
Lead Sponsor