Trial reportBMC cancer2025
Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial.
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04692051 (A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Who cites it
1 citing paper in PubMed.
- Safety and efficacy of PD-1/PD-L1 inhibitors combined with albumin-bound paclitaxel and fluorouracil-based agents as second-line therapy in biliary tract cancers.World journal of surgical oncology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
backgroundThe efficacy and safety of conventional first-line chemotherapeutic regimens for the treatment of advanced biliary tract carcinomas (ABTCs) have been unsatisfactory.
objectivesWe aimed to explore alternative chemotherapeutic regimens capable of providing improved efficacy and fewer side-effects.
designMulticentre, randomised, phase II clinical trial.
methodsPatients with unresectable advanced-stage tumors, or those who have developed recurrence or metastasis following initial radical surgery, between January 2021 and November 2022 were included. The participants were randomised to either a gemcitabine-cisplatin group (GC) or an albumin-paclitaxel-cisplatin group (NC). Progression-free survival (PFS) was the primary outcome, whereas overall survival (OS), and objective response rate (ORR) were the secondary outcomes.
resultsThe trial enrolled 75 patients and had a median follow-up period of 11 months. The median PFS (mPFS) was 7.8 m (95% confidence interval [CI]: 5.4-14.0 m) in the NC group, and 7.0 m (95%CI: 3.9-10.1 m) in the GC group (p = 0.0034, hazard ratio [HR] = 0.5136, 95%CI: 0.3136-0.8411). Median OS for the NC group was 12.4 m (95%CI: 7.3-22.3 m) and for the GC group was 12.1 m (95%CI: 6.7-20.7 m), with no significant differences (p = 0.4592, HR = 0.811, 95%CI: 0.463-1.442). PFS rates at 6 and 8 months were 52.6% vs. 73.0% and 13.2% vs. 35.1% for the NC and the GC group, respectively (p < 0.05). As the secondary endpoint, ORR rates, there was no significant difference between the two groups. GC group had 13 (34.2%) patients achieved ORR, while NC group had 14 (37.8%). Regarding safety, In the context of thrombocytopenia, the incidence was significantly lower in the NC group compared to the GC group (27% vs 50%, P = 0.041). Conversely, with regard to sensory neuropathy, the NC group demonstrated a higher incidence (62.1% vs 36.8%, P = 0.028).
conclusionIn this phase II non-inferiority trial, NC demonstrated comparable efficacy to GC in advanced BTC, with a trend toward improved PFS and a potentially favorable hematological toxicity profile. Further studies are warranted to confirm these findings in the context of a modern immunotherapy-based standard.
trial registrationClinical Trials.gov identifiers: NCT04692051. Registered October 31, 2018. https://www.chictr.org.cn/showproj.html?proj=38440 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.