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The best preoperative treatment for local advanced pancreatic cancer has not yet been determined.
the purpose of this study is to compare the efficacy and safety of Nab-yew alcohol and Nab-yew alcohol-Gissytabin as a multidraught-induced chemotherapy program for localized advanced pancreatic cancer using fluorouracil, folate, olithic acid, and otolium (FOLFIRINOX).
the study was an open-label, randomized Phase 2 trial conducted in 28 centers in Germany, recruiting patients aged 18-75 with histologically diagnosed, untreated localized advanced pancreatic cancer.
After two cycles of Nab-yew alcohol (125 mg/m2) and Gissytabin (1000 mg/m2), patients with no progression or unacceptable adverse reactions were randomly divided into two groups to receive two additional courses of Nab-Yew alcohol and Gisithambin Treatment or 4 courses of FOLFIRINOX (fluorouracil s.400 mg/m2), folate s.400 mg/m2, ilithicon s.180 mg/m2, and Osali platinum s.85 mg/m2.
end of the disease was the surgical conversion rate (complete macro-tumor removal) of randomly grouped patients.
November 18, 2014 - April 27, 2018, a total of 168 patients were recruited, 130 of whom were randomly assigned to the Nab-Yew Alcohol-Gissytabin Group (64) or the Serial FOLINOFIRX Group (66).
After fully induced chemotherapy, 40 (63%) of the 64 patients in the Nab-Yew alcohol-Gissithambin group underwent surgical testing, while 42 (64%) of the 66 patients in the FOLFIRINOX group were treated surgically.
Nab-yew alcohol sictabin and sequential FOLFIRINOX group had 23 and 29 complete macro-tumor removals, respectively, with surgical conversion rates of 35.9% and 43.9% (advantage ratio of 0.72, 95% CI 0.35-1.45, P-0.38), respectively).
the medium follow-up period of 24.9 months, the middle overall survival periods of nab-yew alcohol and Gissital and Sequentia FOLFIRINOX groups were 18.5 months and 20.7 months, respectively (risk ratio 0.86, 95% CI 0.55-1.36, P=0.53).
There was no significant difference between the two groups for other secondary efficacy endpoints, such as the researchers' assessment of progression-free survival and imaging mitigation, CA199 response rate, and R0 excision rate, except for the improvement in the pathological stages of excision tumors in the Sequentimated FOLFIRINOX group (Serial FOLINOX group vs. Nab-Yew alcohol and Gissithamin group: ypT1/2 phase 69% vs. 17%; ypN0 52% vs 17%, P=0.02).
induced chemotherapy, 35 cases (55% vs 53%) of the two groups each had adverse reactions that required emergency treatment at level 3 and above.
the most common were a reduction in neutral granulocytes (Nab-yew alcohol s/gisitabin group vs sequential group: 18 cases (28 percent) vs 16 cases (24 percent),nausea and vomiting (2.3 percent vs. 8 .12 percent), and obstruction bileitis (6.9 percent) vs. 7 .11 percent).
deaths caused by untreated adverse reactions.
The study showed that nab-yew alcohol sictabin and nab-yew alcohol sictabin group followed by FOLFIRINOX sequentage therapy as an induced chemotherapy program for local advanced pancreatic cancer with comparable efficacy and safety.
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