A Phase 2 interventional study of Camrelizumab Nab-Paclitaxel S-1 in Gastric Cancer, sponsored by Hebei Medical University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Hebei Medical University · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.
2,914 studies on the registry are indexed under Stomach Neoplasms; 880 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Hebei Medical University is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
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Blood cell count has to meet the following certeria:
WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
Liver/kidney function has to meet the following certeria:
ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
Exclusion Criteria:
Camrelizumab: 200mg，iv，30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1：According to the body surface area, BSA \<1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA \>1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.
Drug: Camrelizumab Nab-Paclitaxel S-1
Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel
R0-resection rate
There was no residual by the microscope
Time frame: within 3 weeks after surgery
Conversion to negative rate
Exfoliative cytology positive gastric cancer conversion to negative rate
Time frame: within 3 weeks after surgery
Overall survival (OS)
Baseline to measured date of death from any cause
Time frame: 3years
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Time frame: 3years
Objective response rate (ORR)
Baseline to measured stable disease
Time frame: tumor assessment every 6 weeks since the treatment began，up to 3years
Disease control rate (DCR)
Baseline to measured progressive disease
Time frame: tumor assessment every 6 weeks since the treatment began，up to 3years
Tumor regression grade (TRG)
TRG included four grades: Grade 0-3
Time frame: within 3 weeks after surgery
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Hebei Medical University