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更新于：2026-10-15
Hunan Cancer Hospital
更新于：2026-10-15
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ChiCTR2600131168
Effects of Zero-time Exercise Intervention on Immunonutritional Status and Treatment Adherence in Patients with Liver Cancer Undergoing Interventional Therapy: A Randomized Controlled Trial
NCT07602868
A National Multicenter, Prospective, Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Autologous Flap Breast Reconstruction Following Mastectomy
NCT07687225
A National Multicenter, Prospective, Randomized Controlled Trial Comparing Primary Tumor Surgery Followed by Systemic Therapy With Systemic Therapy Alone in Patients With De Novo Stage IV Breast Cancer and Solitary Bone Metastases
100 项与 杭州市肿瘤医院 相关的临床结果
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2026-11-01The Lancet Gastroenterology & Hepatology
On-demand transarterial chemoembolisation combined with atezolizumab and bevacizumab in patients with untreated hepatocellular carcinoma (TALENTACE): a multicentre, randomised, open-label, phase 3 trial
Article
作者: Tong, Lin ; Han, Guohong ; Kudo, Masatoshi ; Liu, Ruibao ; Liu, Zhaoyu ; Liu, Jingfeng ; Lin, Kecan ; Shi, Yanjun ; Bai, Lidan ; Peng, Tao ; Zhu, Jiye ; Wang, Kunyuan ; Zhang, Yonghong ; Gu, Shanzhi ; Dong, Jiahong ; Zhao, Ming ; Song, Jinhua ; Lin, Zhengyu ; Ogasawara, Sadahisa ; Ueno, Makoto ; Hu, Hongtao
BACKGROUND:
TACE is the standard treatment for intermediate-stage hepatocellular carcinoma but has limited survival benefits. TALENTACE evaluated adding atezolizumab and bevacizumab to on-demand TACE versus on-demand TACE alone in patients with systemically untreated, intermediate-to-high tumour burden unresectable hepatocellular carcinoma.
METHODS:
In this randomised, open-label, phase 3 study at 40 centres in China and Japan, patients aged 18 years or older with confirmed, unresectable hepatocellular carcinoma and an anticipated life expectancy of 12 months or more were eligible for inclusion. Eligible patients were required to have an Eastern Cooperative Oncology Group performance status of 0-1, Child-Pugh class A liver function, no previous systemic therapy, and a sum of tumour maximum diameter (cm) and lesion number of six or more based on the six-and-twelve score. Patients were randomly assigned (1:1), using a permuted-block method implemented via an interactive voice and web response system, to on-demand TACE plus atezolizumab 1200 mg intravenously and bevacizumab 15 mg/kg intravenously once every 3 weeks (initiated 14 days to 8 weeks after TACE), or on-demand TACE alone, with TACE administered at the investigators' discretion. The randomisation sequence was generated by an independent biostatistician at the system vendor and was concealed from the sponsor study team and investigators until randomisation; allocation was stratified by baseline α-fetoprotein, prior locoregional therapy, and baseline Vp1/2 (and geographic region in earlier protocol versions). Primary endpoints were investigator-assessed TACE progression-free survival (TACE-PFS; time from randomisation to untreatable [unTACEable] progression, TACE failure or refractoriness, or death), and overall survival, both analysed in the intention-to-treat population. Overall survival was assessed under a prespecified adaptive (group sequential) design comprising two interim analyses and one final analysis. Safety was evaluated in the as-treated population, defined as all randomised patients who received any study treatment, analysed according to the treatment received. This study is registered with ClinicalTrials.gov (NCT04712643) and is ongoing.
FINDINGS:
Between Feb 23, 2021, and August 11, 2023, 342 patients were randomly assigned to TACE plus atezolizumab and bevacizumab (n=171) or on-demand TACE alone (n=171). Median age was 61·0 years (range 21·0-90·0), 66 (19%) of 342 participants were female, 276 (81%) were male, 308 (90%) were Chinese, and 34 (10%) were Japanese. The mean size of the largest target lesion per RECIST 1.1 was 7·7 cm (SD 4·3) in both arms. In the TACE plus atezolizumab and bevacizumab group, 36 (21%) of 171 patients were Barcelona Clinic Liver Cancer stage A, 100 (58%) were stage B, and 35 (20%) were stage C; in the TACE alone group, 42 (25%) of 171 patients were Barcelona Clinic Liver Cancer stage A, 105 (61%) were stage B, and 24 (14%) were stage C. At data cutoff (Feb 28, 2025; median follow-up 26·25 months [IQR 21·16-33·74]), median TACE-PFS was 11·30 months (95% CI 7·52-15·01) with TACE plus atezolizumab and bevacizumab versus 7·03 months (95% CI 5·32-8·41) with TACE alone (hazard ratio [HR] 0·71 [95% CI 0·55-0·92]; two-sided stratified log-rank p=0·0089). Overall survival remains immature and was assessed at the first of the prespecified interim analyses; median overall survival was 34·53 months (99·62% CI 24·80-not evaluable) in the TACE plus atezolizumab and bevacizumab group compared with 35·38 months (99·62% CI 24·74-not evaluable) in the TACE alone group (HR 0·96 [99·62% CI 0·58-1·58]). The most common grade 3-4 adverse events in the TACE plus atezolizumab and bevacizumab group were decreased platelet count (23 [14%] of 166), hypertension (23 [14%]), and post-embolisation syndrome (21 [13%]); in the TACE alone group, the most common were post-embolisation syndrome (23 [13%] of 173), decreased platelet count (12 [7%]), and increased aspartate aminotransferase (12 [7%]). The most common serious adverse event was ascites (eight [5%]) in the TACE plus atezolizumab and bevacizumab group and post-embolisation syndrome (six [3%]) in the TACE alone group. Treatment-related deaths occurred in five patients in the TACE plus atezolizumab and bevacizumab group (gastrointestinal haemorrhage, liver abscess, haemolytic anaemia, hypertension, and unknown death) and three patients in the TACE alone group (post-procedural haemorrhage, ascites, and unknown death). No new safety signals were identified.
INTERPRETATION:
On-demand TACE plus atezolizumab and bevacizumab significantly improved TACE-PFS versus on-demand TACE alone. Overall survival follow-up is ongoing.
FUNDING:
Shanghai Roche Pharmaceuticals.
2026-10-01BIOMEDICINE & PHARMACOTHERAPY
Integrating single-cell transcriptomics and network pharmacology identifies ADORA1 as a candidate receptor for gastrodin derivatives in lung adenocarcinoma
Article
作者: Zhang, Ting You ; Zhang, Zhuang Juan ; Tang, Zaixiang ; Li, Zan ; Ao, Lei
BACKGROUND:
Gastrodin, the main bioactive constituent of Gastrodia elata, shows antitumor activity, but its cell-type-specific mechanism in LUAD remains elusive.
METHODS:
Single-cell RNA-seq data (GSE131907; 208,506 cells, 58 samples, 44 patients) were analyzed with five frameworks: AUCell drug-sensitivity scoring, scTenifoldNet/scTenifoldKnk network/knockout analysis, decoupleR pathway inference, CellChat communication mapping, and MEBOCOST metabolic communication. Ten gastrodin derivatives were ranked by TOPSIS, docked against human ADORA1 (PDB: 5UEN), and validated by surface plasmon resonance (SPR) and an LPS-induced acute inflammation model in Kunming mice (CD68 immunohistochemistry, PARP Western blot, cytokine ELISA).
RESULTS:
ADORA1 was the only core target with both receptor and metabolic-sensor roles. TOPSIS ranked Gastrodin_T9 first (0.592), despite T8's highest network betweenness (0.1389). Docking gave modest affinities (-4.18 to -4.93 kcal/mol) with a shared 12-residue core; T9 covered most of the pocket (37/41). SPR supported the same order for three derivatives (T9 > T7 > T1; apparent K_D 22.79-68.18 μM, n = 3 runs), whereas native-gastrodin signal was too weak for reliable estimation. Lung conditioned medium showed Th1-skewed cytokines: IL-12 rose from 55.5 to 304.1 pg/mL under T9 (p < 0.001), IL-10 was unchanged, and the IL-12/IL-10 ratio shifted four-fold (p < 0.001). Derivatives raised the cleaved-PARP ratio modestly (1.05-1.15-fold), a preliminary change; CD68 staining was heaviest in the native-gastrodin group.
CONCLUSIONS:
These analyses nominate ADORA1 as a candidate receptor and Gastrodin_T9 as a lead among gastrodin derivatives in LUAD. The evidence is hypothesis-generating and biophysical; both candidates warrant mechanistic validation in LUAD-specific models.
2026-10-01JOURNAL OF CLINICAL ONCOLOGY
Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Article
作者: Wu, Zheng ; Lin, Jinguan ; Guo, Ye ; Hou, Tao ; Ruan, Dan-Yun ; Zhou, Yujuan ; Wang, Feng-Hua ; Han, Fei ; Wu, Hai-Jun ; Qiu, Sufang ; Cui, Shuo ; Li, Zhi-Ming ; Qu, Song ; Wu, Yuan ; Li, Mengyun ; Xu, Rui-Hua ; Xiang, Yanqun ; Tang, Linquan ; Gao, Jin ; Liu, Lin ; Fang, Meiyu ; Chen, Qiuyan ; Ma, Yuxiang ; Zhao, Yanqiu ; Ma, Hongzhi ; Liu, Ping ; Han, Chen ; Hu, Man ; Zhao, Qiong ; Su, Fang
PURPOSE:
Patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) have limited therapeutic options after failing platinum and anti–PD-1/PD-L1 therapy. We investigated the efficacy and safety of an epidermal growth factor receptor (EGFR)–directed antibody-drug conjugate (ADC) becotatug vedotin (BV) combined with a PD-1 inhibitor pucotenlimab in this setting of patients.
MATERIALS AND METHODS:
Magic-C001 (ClinicalTrials.gov identifier:
NCT05688605
) is an ongoing, open-label, multicohort, dose escalation (phase I) and expansion (phase II) study in patients with EGFR-positive solid tumors. Eligible patients received pucotenlimab 3.0 mg/kg and BV at 1.8-2.3 mg/kg (phase I) or 2.0 mg/kg (phase II for NPC) once every 3 weeks. The primary end point for phase II was objective response rate (ORR). Secondary end points included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS:
Among 31 patients with NPC at the recommended phase II dose (RP2D) from phase I and II who had received anti–PD-1/PD-L1 and platinum-based therapy, the confirmed ORR was 71.0% (95% CI, 52.0 to 85.8); DCR was 93.5% (95% CI, 78.6 to 99.2). The median DoR and PFS were 14.0 months (95% CI, 5.7 to not estimated) and 12.0 months (95% CI, 6.8 to 15.4), respectively. Median OS was not mature. Most common treatment-related adverse events (TRAEs) were pruritus (71.9%), hypoesthesia (65.6%), anemia (59.4%), and rash (56.3%). TRAEs of ≥grade 3 occurred in 40.6% of patients. No TRAEs led to death.
CONCLUSION:
To our knowledge, we report the first trial combining an ADC with immunotherapy for platinum and anti–PD-1/PD-L1–resistant NPC. BV plus pucotenlimab yielded a notable ORR with exceptionally durable responses and substantially prolonged PFS, alongside manageable toxicities. This regimen may offer a promising anti–PD-1 rechallenge strategy in this population, which is being confirmed in an ongoing, multicenter, randomized controlled, phase III study.
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