Preliminary phase I/II multicenter trial of combined fuzuloparib and realgar-indigo naturalis formula in recurrent platinum-resistant ovarian cancer: clinical and molecular insights
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Junfen XU1, 2, Shaoshuai TANG3, Tingting CHEN1, 2, Yumei ZHOU1, Changkun ZHU1, Shan PAN4, Bairong XIA5, Yuanming SHEN1, 2. Preliminary phase I/II multicenter trial of combined fuzuloparib and realgar-indigo naturalis formula in recurrent platinum-resistant ovarian cancer: clinical and molecular insights[J]. Journal of Zhejiang University Science B, 1998, -1(-1): .
@article{title="Preliminary phase I/II multicenter trial of combined fuzuloparib and realgar-indigo naturalis formula in recurrent platinum-resistant ovarian cancer: clinical and molecular insights",
author="Junfen XU1, 2, Shaoshuai TANG3, Tingting CHEN1, 2, Yumei ZHOU1, Changkun ZHU1, Shan PAN4, Bairong XIA5, Yuanming SHEN1, 2",
journal="Journal of Zhejiang University Science B",
volume="-1",
number="-1",
pages="",
year="1998",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.B2600223"
}
%0 Journal Article
%T Preliminary phase I/II multicenter trial of combined fuzuloparib and realgar-indigo naturalis formula in recurrent platinum-resistant ovarian cancer: clinical and molecular insights
%A Junfen XU1
%A 2
%A Shaoshuai TANG3
%A Tingting CHEN1
%A 2
%A Yumei ZHOU1
%A Changkun ZHU1
%A Shan PAN4
%A Bairong XIA5
%A Yuanming SHEN1
%A 2
%J Journal of Zhejiang University SCIENCE B
%V -1
%N -1
%P
%@ 1673-1581
%D 1998
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B2600223
TY - JOUR
T1 - Preliminary phase I/II multicenter trial of combined fuzuloparib and realgar-indigo naturalis formula in recurrent platinum-resistant ovarian cancer: clinical and molecular insights
A1 - Junfen XU1
A1 - 2
A1 - Shaoshuai TANG3
A1 - Tingting CHEN1
A1 - 2
A1 - Yumei ZHOU1
A1 - Changkun ZHU1
A1 - Shan PAN4
A1 - Bairong XIA5
A1 - Yuanming SHEN1
A1 - 2
J0 - Journal of Zhejiang University Science B
VL - -1
IS - -1
SP -
EP - 0
%@ 1673-1581
Y1 - 1998
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B2600223
Abstract: This study evaluated the efficacy, safety, and molecular correlates of combined treatment with fuzuloparib and realgar-indigo-naturalis formula (RIF) in patients with platinum-resistant ovarian cancer (PROC). Fourteen heavily pretreated patients received fuzuloparib (150 mg BID) plus RIF; RIF was escalated from 1.62 g TID to 2.43 g TID during the initial three-patient dose-escalation phase, after which the other 11 patients received the recommended phase-II dose of 2.43 g TID. The objective response rate (ORR) was 14.3%, with two patients achieving a partial response and 35.7% of patients achieving a CA125 response. The median progression-free survival (mPFS) and overall survival (mOS) were 2.25 and 9.5 months, respectively. Clinical responses were evident irrespective of BRCA status, with a trend toward longer survival among HRD-positive patients. The combination was generally well tolerated, with adverse events predominantly classified as grade 1-2. Integrated proteomic and metabolomic profiling identified pathways related to detoxification, lipid metabolism, and serotonin signaling as potential molecular correlates of poor response, whereas longitudinal profiling revealed dynamic immune and metabolic changes during disease progression. Given the small, clinically heterogeneous, and heavily pretreated cohort, these preliminary efficacy findings should be interpreted with caution. Overall, fuzuloparib plus RIF demonstrated clinical feasibility and preliminary antitumor activity, warranting further evaluation in larger, prospective cohorts.
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