Journal of Zhejiang University

Journal of Zhejiang University SCIENCE B

Accepted manuscript available online (unedited version)

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(s): Junfen XU^1, ², Shaoshuai TANG³, Tingting CHEN^1, ², Yumei ZHOU¹, Changkun ZHU¹, Shan PAN⁴, Bairong XIA⁵, Yuanming SHEN^1, ²
Affiliation(s): ¹Department of Gynecologic Oncology, Women’s Hospital, Zhejiang University School of Medicine, Hangzhou 310006, Zhejiang, China; more
Corresponding email(s): xjfzu@zju.edu.cn, 5312010@zju.edu.cn
Key Words: Fuzuloparib, Realgar-indigo naturalis formula (RIF), Platinum-resistant ovarian cancer, homologous recombination deficiency, Proteomics and metabolomics

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Junfen XU^1,², Shaoshuai TANG³, Tingting CHEN^1,², Yumei ZHOU¹, Changkun ZHU¹, Shan PAN⁴, Bairong XIA⁵, Yuanming SHEN^1,². 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,in press.Frontiers of Information Technology & Electronic Engineering,in press.https://doi.org/10.1631/jzus.B2600223

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Abstract
Chinese Summary
Academic Network
Reviewer Comment

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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On-line Access: 2026-09-24

Received: 2026-04-07

Revision Accepted: 2026-09-09

Crosschecked: 0000-00-00

Cited: 0

Clicked: 200

Citations: Bibtex RefMan EndNote GB/T7714

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