A Phase 1/2 interventional study of PD-1 blockade and Albumin paclitaxel in Esophageal Carcinoma and Neoadjuvant Immunotherapy, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Beijing Friendship Hospital · Phase 1/2, Interventional, and Treatment
This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 89 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Drug: PD-1 blockade · Drug: Albumin paclitaxel · Drug: Carboplatin/Nedaplatin
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Disease-free survival (DFS)
Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.
Time frame: 24 months
Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.
Time frame: 4 weeks after surgery
Major Pathologic Response (MPR)
MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.
Time frame: 4 weeks after surgery
Overall survival (OS)
Overall survival was defined as the time from randomization grouping to the time of death due to any cause.
Time frame: 24 months
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital