This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

[+1]

NCT07625930

/ Not yet recruiting临床2期IIT

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma

Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed.
This study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival.
In this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer.
If successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.

开始日期2027-01-01

申办/合作机构-

NCT07637513

/ Not yet recruiting临床3期

Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.
Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.
The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

开始日期2027-01-01

申办/合作机构

Amgen, Inc.

100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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2,387

项与度伐利尤单抗相关的文献（医药）

2026-10-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy

Article

作者: Orlandini, Serena ; Massolini, Gabriella ; Furlanetto, Sandra ; Pasquini, Benedetta ; Luciani, Francesca ; Floris, Lucrezia ; Gotti, Roberto

This study proposes a Capillary IsoElectric Focusing Analytical Procedure Platform for the charge heterogeneity characterization of monoclonal antibodies. The Analytical Quality by Design approach was implemented to define a robust Method Operable Design Region using Infliximab as the primary model compound. The Analytical Target Profile consisted in a robust Analytical Procedure Platform able to measure the monoclonal antibody isoforms pI values with a bias lower than 4%. Risk Management tools were used to evaluate and control the risk of Analytical Target Profile failure. Risk Analysis identified several potential Critical Procedure Parameters, including urea and methyl cellulose concentrations, cathodic/anodic stabilizer levels, carrier ampholytes composition. The carrier ampholytes composition was optimized utilizing a mixture design. A Scheffé mixture model allowed the selection of experiments, and the Partial Least Squares regression provided high predictive power models for the three defined responses, i.e. the calibration biases at the bracketing markers of Infliximab (pI 9.5 and pI 7.0) and the overall fit of the pI vs. migration time relationship. Within the Method Operable Design Region, the optimized conditions were achieved using as the specific carrier ampholyte a blend constituted of 1.5% at pH 3-10, 1.5% at pH 5-8, and 2.0% at pH 8-10.5. The validation results demonstrated the robustness of the Analytical Procedure Platform, with a bias in pI measurement lower than 0.3% for the markers bracketing the Infliximab isoforms. In addition, the method was validated for linearity, trueness and precision as degree of repeatability in the quantification of the charge variants of Infliximab. Under the same optimized experimental conditions, the method was applied to successfully profile Bevacizumab, Daratumumab, Trastuzumab and Durvalumab. By including molecules exhibiting a broader range of physicochemical properties compared to the Infliximab model, the study confirms the versatility of the proposed Capillary IsoElectric Focusing method for moderately basic to basic antibodies. This work provides a refined, regulatory-compliant conventional electrokinetic methodology for biopharmaceutical quality control.

2026-08-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Mixture cure model analysis of event-free survival in the NIAGARA Trial: Quantifying the cure fraction benefit of perioperative durvalumab in muscle-invasive bladder cancer

Article

作者: Masuda, Hitoshi ; Chen, Wei ; Hirakawa, Akihiro ; Fujii, Yasuhisa ; Yajima, Shugo ; Yoshida, Soichiro ; Fukushima, Hiroshi ; Sato, Hiroyuki ; Tanaka, Hajime

INTRODUCTION:

The NIAGARA trial demonstrated improved event-free survival (EFS) with perioperative durvalumab plus gemcitabine-cisplatin (GC) vs. GC alone in muscle-invasive bladder cancer (MIBC). This analysis applied mixture cure models to explore whether this EFS benefit may reflect an increase in the proportion of patients achieving long-term event-free status, complementing standard hazard ratio analyses.

METHODS:

Reconstructed individual patient data (rIPD) were derived from published Kaplan-Meier curves. Parametric mixture cure models (Weibull, log-logistic, and log-normal) were fitted separately by treatment arm, with model selection based on the Akaike Information Criterion (AIC). Cure regression models decomposed treatment effects into cure and latency components. Sensitivity analyses assessed robustness to reconstruction uncertainty and follow-up duration.

RESULTS:

The rIPD reproduced the published trial results with reasonable concordance (hazard ratio 0.68 vs. reported 0.68). The log-normal model provided the best fit. The estimated cure fraction (π) was 41% (95% confidence interval [CI]: 32%-48%) for the control arm and 60% (95% CI: 55%-65%) for the durvalumab arm, yielding a model-based difference (Δπ) of +19 percentage points (pp) (95% CI: +10 to +29). Akaike weights favored a cure-effect-only model (71%) over a combined cure-plus-latency model (29%), with a latency-only model receiving negligible support (<1%). Perturbation sensitivity analyses indicated that these bootstrap intervals underestimate total uncertainty, with individual-run estimates spanning negative values at plausible reconstruction noise levels.

CONCLUSIONS:

In this exploratory analysis of reconstructed individual patient data, perioperative durvalumab was associated with an estimated +19 pp higher cure fraction (95% CI: +10 to +29); cure regression assigned an Akaike weight of 71% to a pure cure fraction mechanism vs. 29% to a combined cure-plus-latency mechanism. These estimates depend on the reconstructed dataset and on the assumption that the EFS curves have plateaued within the observed follow-up; perturbation sensitivity analyses indicated that at plausible reconstruction noise (SD ≥ 0.5 months) the range of individual-run estimates spans negative values.

2026-08-01·LUNG CANCER

Development of a clinical prediction model using digital device data for interstitial lung disease in patients with unresectable stage III non-small cell lung cancer treated with durvalumab

Article

作者: Sato, Yoshinori ; Kenmotsu, Hirotsugu ; Yamamoto, Nobuyuki ; Koto, Ryo ; Kitagawa, Hiroshi ; Iwao, Chikako ; Ikeda, Satoshi ; Ogi, Mizue ; Hirai, Takehiro

BACKGROUND:

Early detection of interstitial lung disease including radiation pneumonitis (ILD/RP) is crucial in consolidative durvalumab therapy after chemoradiotherapy (CRT) in unresectable stage III non-small cell lung cancer. We conducted a multicenter, noninterventional pilot study to develop clinical prediction models for grade ≥2 ILD/RP following durvalumab treatment by using machine learning algorithms on continuously collected automatic measurements from a wearable device and cough-counting smartphone application, as well as electronic medical record data.

METHODS:

The primary objective of this prospective observational study was to develop a clinical prediction model for grade ≥2 ILD/RP. Eight machine learning algorithms were applied to develop the prediction model. After performing 4-fold cross-validation, the prediction performance was evaluated using the area under the receiver operating characteristic curve (ROC-AUC).

RESULTS:

Of the 145 registered patients, 123 were analyzed. The median age was 68.0 years (range: 39-85), and 79.7% were male. Grade ≥2 ILD/RP occurred in 46 patients. The XGBoost model outperformed the other seven models for the primary objective, with an ROC-AUC of 0.789 (95% confidence interval [CI]: 0.724-0.854). Heart rate showed the highest SHapley Additive exPlanations value for grade ≥2 ILD/RP. The model using patient background and wearable device data (excluding cough app) showed accuracy comparable with the model using all data sources, with an ROC-AUC of 0.794 (95% CI: 0.730-0.859).

CONCLUSIONS:

These findings support the feasibility and acceptability of developing a clinical prediction model for grade ≥2 ILD/RP in patients undergoing durvalumab treatment after CRT.

3,136

项与度伐利尤单抗相关的新闻（医药）

2026-08-04

·医脉通

晚期BTC一线治疗演进：从GC优选治疗到不同化疗骨架下的免疫联合探索

引言长期以来，化疗是晚期胆道恶性肿瘤（BTC）患者治疗的重要基础，其中以吉西他滨联合顺铂（GemCis）为代表的化疗方案奠定了晚期BTC一线治疗的标准地位。然而，单纯化疗带来的生存获益仍存在局限，如何进一步延长BTC患者生存成为临床探索的重要方向。随着对BTC治疗模式探索的不断深入，化疗方案也经历了从单药治疗到联合方案优化的发展过程。近年来，以化疗为基础的免疫联合治疗进一步拓展了晚期BTC的治疗获益，推动治疗模式进入新阶段。本文将重点梳理GemCis与GemOx等化疗骨架的循证依据、毒性谱及临床应用特征，并进一步回顾不同免疫联合化疗方案的研究进展。晚期BTC治疗现状不容乐观，患者存在明显生存瓶颈 BTC具有高度异质性和侵袭性，患者预后差，5年总生存率为21.1%～23.2%，远处转移患者5年总生存率为2.5%～2.8%。目前，手术仍是BTC患者主要的根治性治疗手段，对于早期确诊的BTC患者，手术切除后可能实现治愈1。然而，由于BTC早期缺乏典型临床表现及敏感的诊断标志物，约70%的患者确诊时已经处于晚期，失去了根治性手术机会1-2。因此，系统治疗已成为晚期BTC的重要治疗策略。长期以来，以细胞毒性化疗药物为基础的治疗模式一直占据重要地位，其中以吉西他滨联合铂类为代表的方案逐渐确立了一线治疗标准，为改善患者生存结局发挥了重要作用。近年来，随着免疫检查点抑制剂（ICI）和分子靶向治疗的兴起，晚期BTC患者有了新的治疗选择2。化疗持续引领晚期BTC优选治疗探索，联合免疫策略推动治疗模式升级化疗是晚期BTC系统治疗的重要手段，围绕不同药物组合的探索推动了BTC化疗方案的不断优化，逐步形成了以吉西他滨联合铂类为代表的标准治疗模式。英国多中心II期ABC-01研究验证了GemCis方案的疗效与安全性。该研究纳入86例晚期BTC患者，旨在评估吉西他滨单药及GemCis方案的抗肿瘤活性。研究达到主要终点无进展生存期（PFS），GemCis组6个月PFS率较吉西他滨组更高（57.1% vs. 45.5%）。ABC-01研究结果初步证实，GemCis方案可提升患者6个月PFS率且耐受性良好，为III期研究验证奠定基础3。III期ABC-02研究纳入410例晚期BTC患者，主要终点为总生存期（OS）。经过中位随访8.2个月，GemCis组中位OS为11.7个月，而吉西他滨单药组中位OS为8.1个月[风险比（HR）为0.64；95%置信区间（CI）：0.52-0.80；P<0.001]。ABC-02研究确立了GemCis方案在晚期BTC的一线标准治疗地位4。在安全性方面，GemCis方案的不良反应以血液学毒性与肾毒性为主要特征。III期研究数据显示，3~4级中性粒细胞减少、血小板减少是常见的血液学不良反应（AE）；同时顺铂具有明确的肾毒性风险，临床需重视利尿处理。此外，GemCis组肝功能恶化发生率低于吉西他滨单药组，可能与更好的疾病控制有关4。两项研究证实，与吉西他滨单药相比，GemCis方案显著改善晚期BTC患者生存结局，且总体安全性可接受。自2010年起，GemCis方案成为晚期BTC的一线治疗方案2。然而，随着 GemCis 在临床实践中的广泛应用，其治疗相关不良反应及管理特点也逐渐受到关注。顺铂的肾毒性、胃肠道反应以及对水化支持的需求，增加了部分患者的治疗管理负担。因此，后续研究开始探索包括 GemOx 在内的其他化疗方案，以期为不同患者群体提供更多治疗选择。需要指出的是，这些方案并非对 GemCis 的单向优化，而是在疗效、毒性谱和临床应用场景方面各具特点。以吉西他滨联合奥沙利铂（GemOx）方案为代表的化疗方案在晚期BTC中开展了临床探索。一项国际多中心II期研究显示，根据RECIST标准，GemOx治疗组确认的部分缓解（PR）为10例（14.9%），24例（35.8%）疾病稳定（SD）。意向治疗人群的中位OS为8.8个月，PFS为3.4个月。此外，非胆囊癌患者的客观缓解率（ORR）为20.5%，胆囊癌患者ORR为4.3%，提示GemOx方案对非胆囊癌具有较好的疗效，但对胆囊癌疗效不佳5。后续真实世界研究结果进一步验证，在对照试验和真实世界临床环境中，GemOx方案治疗晚期BTC的疗效表现相当：GemOx方案中位OS为8.9个月，PFS为5.3个月。在真实世界研究中，97%的患者使用的奥沙利铂剂量低于既往III期试验中的标准剂量，且多数患者接受了奥沙利铂和/或吉西他滨的进一步减量治疗，说明较低剂量的奥沙利铂提示在临床实践中具有一定可操作性，但仍需更多前瞻性证据支持6。在安全性方面，尽管采取了系统性预防措施，各严重程度级别的恶心（82.1%）和呕吐（56.7%）仍为常见不良反应。相较于GemCis方案，GemOx方案中的中性粒细胞减少症和血小板减少症发生率较低。然而，GemOx治疗过程中外周感觉神经病变较为常见，且神经毒性风险随着治疗周期增加而累积。GemOx方案中有70.1%的患者出现3～4级AE，最常见的为中性粒细胞减少、血小板减少、疼痛和呕吐5。除GemOx外，CapOx（卡培他滨联合奥沙利铂）也探索了不同化疗组合的价值。CapOx通过口服氟嘧啶类药物替代部分静脉化疗流程，进一步提高了治疗便利性。一项多中心III期研究对比了GemOx方案与卡培他滨联合奥沙利铂（CapOx方案）在晚期BTC一线治疗中的疗效。共有114例患者随机接受GEMOX方案，108例接受CapOx方案。两组在ORR（P=0.171）和中位OS（P=0.131）方面均无显著统计学差异。但GEMOX组的中位PFS为5.3个月，CapOx组为5.8个月；两组的6个月PFS率分别为44.5%和46.7%（95%CI：12%-16%），CapOx与GEMOX相比具有显著非劣效性。因此，CapOx方案为BTC患者的一线治疗提供了新的选择。在安全性方面，血小板减少症和恶心是两组中最常见的不良反应，但大多易于管理和控制。最常见的3～4级AE为中性粒细胞减少症和血小板减少症，两组间3～4级AE发生率无显著差异（P=0.158）。相比之下，GemOx组血液学毒性（中性粒细胞减少、血小板减少）发生率更高，CapOx组手足综合征更常见7。为改善铂类化疗方案的耐受性，日本III期JCOG1113（FUGA-BT）研究探索了吉西他滨联合S-1（GS方案）的疗效和安全性8。研究结果证实GS方案的疗效不劣于GemCis方案，GemCis组中位OS为13.4个月，GS组中位OS为15.1个月（HR=0.945；90%CI：0.78–1.15；非劣效性检验P=0.046）。中位PFS在GemCis组为5.8个月，GS组为6.8个月（HR=0.86；95%CI：0.70–1.07）。在安全性方面，两种治疗方案均具有良好的耐受性。3～4级贫血、血小板计数下降和周围感觉神经病变在GemCis组中更频繁发生，而腹泻、口腔黏膜炎、斑丘疹及皮肤色素沉着则在GS组中更为常见。在GC组中，35.1%的患者出现具有临床意义的AE；在GS组中为29.9%。研究结果证实GS方案的疗效不劣于GemCis方案，且毒性反应可接受，因此，该研究提示GS方案为BTC患者提供了新的选择8。总体而言，不同化疗方案的发展并非简单的相互替代，而是在疗效、安全性和治疗便利性之间寻求平衡。GemCis凭借ABC-02研究建立的循证证据，仍是晚期BTC化疗的核心基础；而GemOx、CapOx及GS等方案则针对GemCis方案相关毒性、给药方式及患者耐受性进行了优化探索，丰富了临床治疗选择。需注意，不同研究在入组人群、地区分布、化疗骨架、给药周期及后续治疗方面存在差异，跨研究疗效数值不宜直接比较。尽管吉西他滨联合铂类的方案确立了晚期BTC的化疗标准，但单纯化疗中位OS仍不足1年，患者生存获益存在明显瓶颈。随着精准医学与肿瘤治疗的快速发展，免疫治疗等新型治疗手段在BTC领域展现出应用潜力，成为化疗联合探索的重要方向。免疫联合GemCis方案： TOPAZ-1研究是全球首个免疫联合化疗一线治疗BTC获得阳性结果的Ⅲ期临床试验9，基于TOPAZ-1的研究结果，度伐利尤单抗联合GemCis已经成为晚期BTC的一线标准治疗方案。该研究最新4年随访数据显示10，度伐利尤单抗联合GemCis的4年OS率达到11.8%，而对照组仅为4.3%。联合治疗组中位OS为13.0个月，死亡风险较对照组降低25%。关键里程碑分析显示，联合治疗组在24个月、36个月和48个月的OS率均优于对照组。在安全性方面，度伐利尤单抗联合GemCis的安全性特征与既往分析一致，未发现新的安全性信号10。继TOPAZ-1研究之后，KEYNOTE-966研究进一步验证了靶向PD-1/PD-L1的ICI与化疗联合应用治疗晚期BTC的有效性11。KEYNOTE-966研究结果显示，与GemCis方案相比，帕博利珠单抗联合GemCis组的中位OS为12.7个月，安慰剂组为10.9个月（HR 0.83 [95% CI 0.72–0.95]；单侧检验p=0.0034 [显著性界值p=0.0200]）。两组患者PFS和ORR均无显著差异。在实际治疗人群中，帕博利珠单抗组3～4级治疗相关AE发生率为70%，安慰剂组为69%，两组均有≥50%患者出现中性粒细胞减少和贫血11。免疫联合GemOx方案：国内多中心III期KN035-CN-005研究证实，在GemOx方案中联合使用恩沃利单抗可显著改善晚期BTC患者OS12。恩沃利单抗联合GEMOX方案与GEMOX单药化疗中位OS分别为10.9个月和8.6个月（HR=0.723，P=0.0016）。该研究结果再次验证了免疫联合化疗相较于单纯化疗的OS获益，从不同化疗骨架和研究背景下进一步支持免疫联合化疗的治疗理念。在安全性方面，恩沃利单抗联合GEMOX方案的安全性可控，且与各药物已知的安全性特征一致，未发现新的安全性信号12。总体而言，GemCis方案长期以来凭借成熟的循证基础，成为CSCO指南晚期BTC一线治疗1A类推荐方案13、NCCN指南晚期BTC一线系统治疗1级推荐方案14。随着免疫治疗的发展，TOPAZ-1和KEYNOTE-966研究进一步证实了以GemCis为基础联合ICI能够带来生存获益，使GemCis化疗骨架在全球范围内的标准治疗地位进一步巩固。相比之下，GemOx方案在治疗便利性以及部分患者耐受性方面具有一定优势；但同时，其累积性周围神经毒性也是临床应用中需要关注的问题。因此，在联合治疗不断发展的背景下，化疗骨架的选择仍具有临床意义。未来治疗决策不仅需要关注抗肿瘤疗效，也需综合考虑患者长期治疗耐受性等因素，在循证证据与个体化治疗需求之间实现平衡。 BTC治疗的未来发展与前景展望近年来，BTC系统治疗取得长足进展，以吉西他滨联合铂类为代表的标准化疗方案始终是晚期BTC系统治疗的基石，经过多年临床实践与方案优化，化疗仍是目前晚期BTC患者应用广泛、循证证据充分的治疗方法之一，并为后续联合治疗策略的开展提供了重要基础。在此基础上，新型靶向药物与免疫治疗策略的发展为联合治疗提供了更多有力手段。与此同时，不同作用机制的联合治疗模式持续拓展，为进展期BTC患者带来了更多元的治疗选择，提升了BTC患者的临床获益。但是由于BTC本身恶性程度高，肿瘤异质性大，导致治疗结局差异较大，总体治疗效果仍不够理想1。因此，针对BTC的精准化诊疗体系构建与联合策略的探索，是未来领域发展的重要方向。未来，应探索更精准的免疫治疗策略，寻找BTC免疫微环境的生物标志物，是提高免疫治疗的应答率的关键。同时，优化以化疗为基础的联合治疗模式，目前化疗联合免疫检查点抑制剂、靶向药物的研究仍在进行中，部分研究已显示出联合治疗具有更好的肿瘤抑制效果。FGFR、IDH1抑制剂的耐药机制也是未来研究的重点，开发新一代抑制剂或探索靶向与化疗的联合策略，有望突破耐药瓶颈。此外，个体化肿瘤疫苗在肝内胆管癌的治疗中展现出较大潜力，为晚期BTC患者展示了新的治疗前景。最后，也应通过下一代测序技术筛选BTC患者的关键驱动基因，尤其应关注其中罕见的突变如NTRK融合，实现真正的精准治疗2。小结胆道恶性肿瘤具有高度异质性和侵袭性，晚期患者整体预后仍存在较大挑战。以吉西他滨联合铂类为代表的化疗方案经过多年探索，确立了晚期BTC系统治疗的基石地位，其中GemCis凭借明确的生存获益成为经典一线化疗方案。随着治疗理念不断发展，免疫检查点抑制剂与化疗联合进一步突破了单纯化疗的疗效瓶颈，TOPAZ-1等III期研究推动晚期BTC进入免疫联合治疗时代。未来，基于分子分型、免疫微环境特征及精准生物标志物的治疗策略探索，将有望进一步优化患者分层，实现更加精准和个体化的治疗，为晚期BTC患者带来更多长期获益。参考文献 1. 王敬晗, 马文聪, 章程, 等. 胆道恶性肿瘤的治疗现状与未来展望[J]. 临床肝胆病杂志, 2025, 41(12): 2441-2446 2. 李相成,黄彬,长江.晚期胆道恶性肿瘤免疫与靶向治疗的现状与进展[J].中华消化外科杂志,2025,24(7):832-839. 3. Valle JW, Wasan H, Johnson P, et al. Gemcitabine alone or in combination with cisplatin in patients with advanced or metastatic cholangiocarcinomas or other biliary tract tumours: a multicentre randomised phase II study - The UK ABC-01 Study. Br J Cancer. 2009 Aug 18;101(4):621-7. 4. Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemci tabine versus gemcitabine for biliary tract cancer[J]. N Engl J Med,2010,362(14):1273-1281. 5. André T, Reyes-Vidal JM, Fartoux L, et al. Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study. Br J Cancer. 2008;99(6):862-867. 6. Lagenfelt H, Blomstrand H, Elander NO. Real-World Evidence on Palliative Gemcitabine and Oxaliplatin (GemOx) Combination Chemotherapy in Advanced Biliary Tract Cancer. Cancers (Basel). 2021 Jul 13;13(14):3507. 7. Kim ST, Kang JH, Lee J, et al. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. 8. Morizane C, Okusaka T, Mizusawa J, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019;30(12):1950-1958. 9. Oh DY, et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. 10. Oh DY, et al. Four-year survival and safety analysis from the Phase 3 TOPAZ-1 study of durvalumab plus chemotherapy in biliary tract cancer. 2026 EASL LCS. 11. Kelley RK, Ueno M, Yoo C, et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10391):1853-1865. 12. Shukui Qin, et al. Envafolimab (KN035) plus gemcitabine and oxaliplatin (GEMOX) compared with GEMOX as first-line treatment for Chinese patients with advanced biliary tract cancer: A randomized, open-label, multi-center, phase III pivotal trial. 2026 ASCO, Abstract 4118. 13. 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）胆道恶性肿瘤诊疗指南2025. 14. NCCN Clinical Practice Guidelines in Oncology: Biliary Tract Cancers. Version 1.2026. National Comprehensive Cancer Network; 2026. 审批编号：CN-189235 有效期至：2027-07-28 本材料由阿斯利康提供，仅供医疗卫生专业人士参考，不用于推广目的。若涉及具体药物使用，请参考相关药物说明书，阿斯利康不建议您将产品超说明书使用。撰写：Kiana 审校：Arrival 排版：Aurora 执行：Zelda 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

2026-08-04

·药事纵横

阿斯利康2026H1：中国区遇冷下滑5%，Enhertu狂飙30亿美金

2026年7月27日，阿斯利康发布上半年重磅财报，全球总营收达306.72亿美元，固定汇率下同比增长6%，整体维持稳健增长态势。拆分区域与业务结构可见明显的结构性分化：美国、欧洲市场稳步上行，新兴市场整体增长3%，唯独核心战略市场中国区逆势下滑5%，录得35.1亿美元营收，成为全球增长的唯一拖累项。与此同时，公司管线迭代进入关键拐点，传统老牌专利药持续承压，而以Enhertu为核心的ADC管线、Truqap为代表的全新靶点药物、罕见病板块全面爆发，重构了阿斯利康的全球增长底盘。这份冰火两重天的半年报，不仅折射出跨国药企在华发展的新时代困境，更清晰勾勒出阿斯利康未来数年的全球战略重心、管线取舍逻辑与长期竞争格局。表2026H1阿斯利康核心业务数据中国区“失速”35.1亿美元从财报核心数据来看，2026上半年阿斯利康中国区35.1亿美元的营收、5%的同比下滑，绝非阶段性波动，而是多重行业变量叠加后的必然结果，标志着跨国药企在华“粗放式高增长”时代正式落幕。对比全球市场表现，美国市场同比增长8%、欧洲增长8%、新兴市场整体增长3%，中国区作为阿斯利康深耕多年的核心增量市场，首次出现明显的增长失速，彻底打破了过去十年持续领跑全球的固有格局，成为全球业绩的最大拖累板块。这一数据变化的背后，是政策、竞争、合规、产业迭代四重逻辑的深度重塑。首先，集采与医保常态化降价的持续渗透，持续挤压老牌产品利润空间。阿斯利康虽是最早适配中国集采规则的跨国药企之一，具备成熟的准入与放量经验，但心血管、呼吸等传统优势成熟管线，大多已过专利期，持续面临国产仿制药的低价冲击与医保续谈降价压力。核心慢病大单品达格列净上半年全球营收同比下滑11%，其中国市场放量也同步受限，传统现金牛产品的增长红利彻底消退，无法再为中国区提供稳定营收支撑。长期依赖成熟品种的增长模式已然失效，老牌产品的收入收缩效应在2026年集中显现。其次，医疗反腐常态化与合规深化，重塑了新药准入与临床推广节奏。2026年国内医疗合规监管进入深水区，新药入院流程、学术推广、临床准入的审核标准全面收紧。相较于过往快速入院、快速放量的节奏，当前创新药的商业化落地周期显著拉长，即便拥有全球优质创新管线，也难以实现短期爆发式增长，直接导致Enhertu、Truqap等全球爆款新药，在中国市场的渗透速度远滞后于海外，无法对冲传统产品的营收下滑缺口。更深层的核心变量，是本土创新药企的全面崛起与赛道围剿。过去跨国药企凭借靶点先发、技术壁垒、学术优势垄断高端市场，而当前国内Biotech在ADC、EGFR-TKI、GLP-1等核心热门赛道实现全面突破，同质化产品集中上市，以高性价比、本土化服务、快速临床迭代的优势，对阿斯利康明星产品形成全方位围剿。以EGFR-TKI赛道为例，齐鲁、翰森、艾力斯等本土企业持续迭代新品，持续分流奥希替尼国内市场份额；ADC赛道更是百花齐放，国产多款优质产品进入临床后期，持续挤压Enhertu的本土增长空间。综合来看，中国区5%的下滑并非短期阵痛，而是阿斯利康在华发展的长期战略拐点。企业正式告别“躺着赚钱”的时代，进入精细化深耕、创新驱动、本土化适配的阵痛转型期。未来中国区能否重回增长轨道，核心不再依赖传统慢病老药的存量收割，而是取决于Enhertu、Truqap、度伐利尤单抗等全球创新爆款的本土化快速获批、医保准入与临床放量能力，能否完成新旧动能的彻底切换。肿瘤帝国的“新三驾马车” 肿瘤业务作为阿斯利康第一大核心板块，2026上半年创收141.23亿美元，同比大涨15%，成为全球业绩最核心的增长引擎，彻底对冲了中国区与传统慢病药的营收压力。当前肿瘤板块已完成管线迭代，告别单一奥希替尼依赖，形成Enhertu、度伐利尤单抗、Truqap组成的全新增长三驾马车，但同时老牌主力增速乏力、落后管线果断出清，展现出成熟的管线迭代与取舍逻辑。 Enhertu（德曲妥珠单抗）无疑是当前全球ADC赛道的绝对霸主，上半年交出29.61亿美元的炸裂销售额，全年营收有望突破60亿美元，坐稳全球“ADC药王”宝座。这款与第一三共合作的明星产品，彻底验证了精准生物导弹的时代红利，其核心竞争力绝非单一适应症支撑，而是持续拓展的广谱实体瘤布局。目前Enhertu已全面覆盖HER2阳性、HER2低表达乳腺癌，同时在胃癌、非小细胞肺癌、结直肠癌等多个实体瘤赛道持续突破，不断拓宽患者人群与临床适应症。凭借碾压级的疗效优势、扎实的循证数据、广谱的瘤种布局，Enhertu持续收割全球实体瘤精准治疗市场，成为阿斯利康未来五年最确定的增长核心。同时，另一款合作ADC产品Datroway（德达博妥单抗）上半年贡献0.98亿美元营收，形成ADC双产品矩阵，进一步巩固赛道优势。相较于Enhertu的体量优势，全球首创AKT抑制剂Truqap（卡匹色替）的高速增长更具战略意义。上半年该产品销售额达4.31亿美元，同比暴涨41%，增速领跑整个肿瘤管线。作为稀缺性First-in-class靶点药物，Truqap补齐了阿斯利康肿瘤信号通路的布局短板，跳出CDK4/6、EGFR等内卷赛道，实现差异化卡位。其持续高增的市场表现，验证了公司在肿瘤通路创新布局的前瞻性，标志着阿斯利康正式进入后CDK4/6时代，拥有了全新的差异化增长极，摆脱对传统靶向药的单一依赖。在新品狂飙的同时，老牌王牌产品尽显增长疲态，管线迭代压力凸显。曾经的全球肿瘤药王Tagrisso（奥希替尼）上半年营收37.75亿美元，同比仅增长6%，增速大幅放缓，天花板效应显著。经过多年临床普及，奥希替尼市场渗透率已趋于饱和，常规治疗场景增长乏力，未来只能依靠联合用药策略、新适应症拓展突破增长瓶颈，后续增量空间大幅受限。更体现阿斯利康成熟产业思维的是其果断的管线“断舍离”。2026年上半年，公司主动终止两款ADC管线研发，分别为CLDN18.2 ADC（AZD4360，I期）与EGFR/cMET双靶点ADC（Tilatamig samrotecan，II期）。这一决策精准契合国内赛道格局：当前国内CLDN18.2 ADC赛道内卷严重，国产管线进度领先、数据优异，海外产品竞争优势持续弱化；EGFR/cMET双靶点赛道同质化严重，差异化价值不足。主动止损落后、低效管线，将研发资源集中聚焦Enhertu、Truqap等高壁垒、高确定性核心资产，是跨国药企适配全球竞争格局的明智之举，也印证了顶级药企“不盲目追热点、重临床价值、重资源效率”的研发逻辑。罕见病挑起“大梁” 如果说肿瘤板块是阿斯利康的进攻性增长引擎，那么罕见病板块就是企业穿越周期、对冲风险的核心战略缓冲。2026上半年阿斯利康罕见病业务营收49.11亿美元，同比增长11%，增速远超心血管等传统成熟板块，在核心慢病药专利到期、肿瘤老药增速放缓、中国市场承压的多重压力下，罕见病板块凭借高壁垒、长周期、稳现金流的特性，成为公司最稳健的基本盘。板块内部产品迭代结构持续优化，完美完成新旧动能接替。老牌重磅C5单抗Soliris（依库珠单抗）受竞品冲击，上半年销售额同比下滑22%至7.78亿美元，增长持续乏力；但新一代产品Ultomiris（瑞利珠单抗）强势接棒，上半年营收25.84亿美元，同比增长14%，彻底填补老药下滑缺口，完成从Soliris到Ultomiris的完美迭代，展现出极强的自我革新能力。而板块最大惊喜来自低磷酸酯酶症新药Strensiq（阿司福酶α），上半年销售额达10.53亿美元，同比暴涨40%，成为罕见病赛道增速最快的单品之一，持续打开细分小众病种的市场空间。同时，神经纤维瘤疗法Koselugo（司美替尼）稳步增长，上半年营收3.47亿美元，同比增长21%，进一步丰富罕见病管线收入结构。从战略维度来看，罕见病板块的爆发具备极强的对冲价值。当前阿斯利康传统核心产品达格列净受专利到期影响，上半年营收同比下滑11%，传统慢病现金牛业务持续收缩；中国区市场受政策、竞争、合规多重影响出现营收下滑，整体业务承压明显。而罕见病药物依托极高的技术壁垒、稀缺的临床价值、极少的竞品竞争、稳定的医保支付体系，不受集采降价、同质化内卷的冲击，能够持续输出稳定现金流，成为企业抵御行业周期波动、对冲传统业务风险的核心底牌。此次罕见病板块的持续高增，也彻底改写了阿斯利康的企业标签。依托收购Alexion获得的优质罕见病资产，阿斯利康成功摆脱“纯肿瘤药企”的单一标签，构建起“肿瘤创新+罕见病稳基+慢病兜底”的多元业务体系。在全球医药行业投融资遇冷、内卷加剧、政策管控趋严的大背景下，罕见病等高壁垒细分赛道的战略价值持续凸显，为阿斯利康长期稳健发展提供了不可替代的韧性支撑。最后 2026年上半年财报，是阿斯利康战略转型的真实缩影。中国区5%的营收下滑，宣告跨国药企在华粗放增长时代终结，正式进入精细化深耕、创新驱动的转型阵痛期；肿瘤板块完成管线迭代，Enhertu、Truqap强势崛起，老旧管线果断出清，持续巩固全球创新壁垒；罕见病赛道逆势高增，成为企业穿越行业周期的核心缓冲垫。从依赖传统慢病老药、单一肿瘤大单品，到创新肿瘤药、高壁垒罕见病双轮驱动，阿斯利康的结构优化已初见成效。未来，能否依托全球顶尖创新管线，完成中国市场的本土化适配、快速放量，破解在华增长困局，将是这家跨国巨头能否持续领跑全球创新药企的核心关键。信息来源：阿斯利康财报及官网立即扫码加入药事纵横交流群

2026-08-04

·BioSpace

As portfolio erodes, BMS stands to gain a lot from rumored AstraZeneca merger

iStock/ honster While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be more mixed. As rumors swirl about a potential Bristol Myers Squibb/AstraZeneca mega-merger, analysts say such a deal could help BMS in particular offset looming portfolio erosion. Over the weekend, The Financial Times reported that Big Pharmas BMS and AstraZeneca—each worth more than $130 billion—are in discussions about a possible merger. If it comes to pass, it would be the largest in the industry’s history. Patent cliffs may explain some of the reasoning behind a potential transaction. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); “Both companies face meaningful loss of exclusivity for key brands by 2030, totaling to roughly $50 billion of revenue reported in 2025,” analysts at William Blair wrote in a Monday note. “This would place additional emphasis on operational synergies between the two companies to justify the transaction.” Though both organizations are experiencing and face upcoming patent expirations, BMS in particular is entering “a difficult period of revenue headwinds from loss of exclusivity for several products,” William Blair wrote. In addition to ongoing patent losses for CTLA-4 inhibitor Yervoy and multiple myeloma treatment Revlimid, the pharma is also staring down impending exclusivity losses for two of its top-selling drugs: Pfizer-partnered blood thinner Eliquis and PD-1 checkpoint inhibitor Opdivo. Both patent losses are expected to take effect in the U.S. in 2028. Last year, Eliquis brought in $14.4 billion in global sales, while Opdivo secured $10 billion in worldwide revenue—together accounting for half of BMS’ entire $48.2 billion revenue . Leerink Partners in a Monday note projected total BMS revenues of $38.7 billion in 2030. “Additional bolt-on acquisitions may prove difficult to offset the decline of legacy products,” William Blair wrote. “Therefore, a large strategic merger could offer a near-term opportunity for value creation for shareholders.” But the patent cliffs also muddy the rationale behind a merger. “We believe the strategic and financial rationale is mixed, especially for AZN, given the company’s strong pipeline and organic growth outlook,” Leerink wrote. While a merger with BMS could boost U.K. pharma AstraZeneca’s exposure in the U.S., the analysts said, the 2028 patent cliffs “raise questions around whether a transaction would improve AZN’s long-term growth profile.” Patents 5 Pharma Powerhouses Facing Massive Patent Cliffs—And What They’re Doing About It Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others. February 19, 2025 · 10 min read · Tristan Manalac Read more When news first broke over the weekend of merger chats, analysts largely brushed off the idea as “unlikely,” citing the fact that the companies have competing products that would greatly complicate an antitrust review. William Blair believes a transaction could require divestitures, particularly given overlap between AstraZeneca’s Imfinzi and BMS’ Opdivo. Beyond the high scrutiny the overlapping immunotherapy pro face, the pharma’s marketed portfolios are mostly complementary instead of overlapping, Leerink said. Leerink also looked to several key clinical catalysts coming up this year and next that “could introduce volatility” for AstraZeneca if unsuccessful. These readouts include Phase 3 data for several BMS drugs: admilparant in idiopathic pulmonary fibrosis in 2026, milvexian in atrial fibrillation expected early next year, and Cobenfy in Alzheimer’s disease psychosis, now expected in 2027 after being previously delayed . “It is interesting that merger talks are happening now, ahead of major pivotal readouts,” Leerink analysts mused in a separate note on Sunday. AstraZeneca also has high-pro 3 readouts coming up, including for its TROP-2 antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), marketed as Datroway. A transaction could provide a meaningful cushion for the company if readouts disappoint, especially as AstraZeneca aims for $80 billion in revenue by 2030 , Leerink wrote. The analysts currently model the company narrowly cresting that goal at $79.8 billion. As of market close on Monday, AstraZeneca’s shares fell about 7% to $157.97, while BMS was flat on the news at $65.47. Mergers & acquisitions ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year. August 3, 2026 · 3 min read · Annalee Armstrong Read more

并购免疫疗法专利到期

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01XC28	DB11714

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	美国	AstraZeneca UK Ltd.	2026-05-28
胃癌	欧盟	AstraZeneca AB	2026-03-16
胃癌	冰岛	AstraZeneca AB	2026-03-16
胃癌	列支敦士登	AstraZeneca AB	2026-03-16
胃癌	挪威	AstraZeneca AB	2026-03-16
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处腺癌	美国	AstraZeneca UK Ltd.	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
微卫星稳定型实体瘤	临床3期	西班牙	AstraZeneca PLC	2024-12-30
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	巴西	AstraZeneca PLC	2023-11-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05194293 (CTgov)	临床2期	肝细胞癌	4	Regorafenib+Durvalumab	選觸觸顧襯醖壓糧獵選 = 艱醖簾鑰觸齋製網選醖廠鹽鏇餘壓醖壓繭鬱淵 (憲鹽衊構顧衊醖構網蓋, 願網蓋衊膚觸鹽構膚襯 ~ 簾淵簾簾淵膚築廠襯範) 更多	-	2026-07-20
NCT03780608 (ESMO_GI2026 \| ESMO_GCC2026)	临床2期	晚期胃癌	14	Ceralasertib plus durvalumab	淵膚繭簾衊淵觸糧製構(顧獵鬱齋遞壓遞糧鬱網) = 醖艱觸衊觸繭蓋廠膚廠遞築鬱願願遞鑰鬱衊鹹 (獵廠願遞壓糧憲窪鹽積 ) 更多	积极	2026-07-02
MARVEL (ESMO_GI2026 \| ESMO_GCC2026)	临床1期	晚期胆道癌一线	28	immunomodulatory radiation + gemcitabine + cisplatin + durvalumab	顧蓋淵夢餘簾製窪積窪(鏇夢鹽窪積鹹蓋襯醖蓋) = 鑰憲鹽糧齋艱窪夢膚蓋糧範製積構製醖觸窪淵 (製範壓齋糧糧觸艱鹽糧, 18.6 ~ 55.9) 更多	积极	2026-07-02
NCT06904170 (Prodige 89 UCGI 44 ALICE, ESMO_GI2026 \| ESMO_GCC2026)	临床2/3期	肝细胞癌	196	-	淵築夢蓋鑰蓋製糧壓顧(願網鹹廠願網窪選鬱艱) = 顧夢衊醖選衊襯齋網鹽艱願鑰獵遞選淵鹽襯齋 (簾鏇簾選齋鹽製鬱繭網 )	积极	2026-07-02
				TremelimumabDurvalumab + TremelimumabDurvalumabab	淵築夢蓋鑰蓋製糧壓顧(願網鹹廠願網窪選鬱艱) = 廠衊網鹹獵遞製鹹壓艱艱願鑰獵遞選淵鹽襯齋 (簾鏇簾選齋鹽製鬱繭網 )
NCT04605731 (ESMO_GI2026 \| ESMO_GCC2026)	临床1期	局部晚期肝细胞癌	25	Y90 + durvalumab + tremelimumab	製網艱構襯淵憲遞鬱遞(壓蓋獵鏇網積夢選鹽簾) = 鏇製顧鑰餘遞選獵醖蓋窪積蓋簾獵積艱願鹹範 (夢憲網觸廠願膚觸構壓 ) 更多	积极	2026-07-02
NCT05883644 (SIERRA, ESMO_GI2026 \| ESMO_GCC2026)	临床3期	不可切除的肝细胞癌一线	111	Tremelimumab + Durvalumab	鬱憲窪膚餘齋醖齋窪鹽(淵憲夢鬱鑰夢齋構膚鏇) = 鏇窪範遞顧選艱糧夢壓窪醖餘範壓鑰憲窪淵壓 (夢壓餘醖窪膚願憲糧積, 8.5 ~ 22.4) 更多	积极	2026-07-02
				Tremelimumab + Durvalumab (Child-Pugh B7/B8 with ECOG 0-1)	鬱憲窪膚餘齋醖齋窪鹽(淵憲夢鬱鑰夢齋構膚鏇) = 艱糧獵積選簾觸鹹壓觸窪醖餘範壓鑰憲窪淵壓 (夢壓餘醖窪膚願憲糧積, 1.4 ~ 18.7) 更多
ESMO_GI2026 \| ESMO_GCC2026	N/A	肝细胞癌	71	Atezolizumab plus Bevacizumab	膚齋蓋簾糧構鑰繭製鹽(範鹹遞夢衊鬱鏇簾範鹹) = 壓簾襯遞選範淵壓願憲顧鹹襯窪艱淵築壓膚簾 (廠衊鏇淵夢鏇蓋獵繭糧 ) 更多	积极	2026-07-02
				Durvalumab plus Tremelimumab	齋夢遞壓餘襯衊窪鏇餘(醖繭積壓鑰顧襯醖鹽鹽) = 衊網醖選糧選繭衊製壓糧繭淵顧鹽醖壓網夢夢 (齋繭醖齋繭築顧襯鹽衊 )
TOPAZ-1 (ESMO_GI2026 \| ESMO_GCC2026)	N/A	晚期胆道癌一线	1,358	Cisplatin, gemcitabine, and durvalumab (TOPAZ-1-in)	廠遞繭簾齋餘衊鹹蓋膚(淵鬱鹽鏇鑰夢顧鹹膚衊) = TOPAZ-1-out patients experienced no significant increase in adverse events compared with the TOPAZ-1-in group. 蓋蓋鏇範壓窪積積醖糧 (夢餘衊淵簾獵觸網網遞 ) 更多	积极	2026-07-02
				Cisplatin, gemcitabine, and durvalumab (TOPAZ-1-out)
NCT04269200 (DUO-E, ESMO_GCC2026)	临床3期	子宫内膜癌一线 pMMR	1,360	Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab + olaparib	簾夢獵鹽網鑰願衊窪膚(襯網鹽膚鏇構齋鏇憲願): OR = 0.88 (95.0% CI, 0.54 ~ 1.44) 更多	积极	2026-06-18
				Pembrolizumab + CP followed by pembrolizumab
NCT03691714 (P397, CTgov)	临床2期	复发性头颈癌 \| 转移性头颈部鳞状细胞癌 \| 转移性肿瘤	35	Cetuximab+Durvalumab	積廠蓋餘鏇獵築夢襯齋 = 選鹽遞觸願艱鏇範壓繭夢選繭淵鑰繭醖積夢鏇 (壓鹹製選淵餘醖衊觸壓, 醖觸齋築餘願繭憲鬱壓 ~ 觸構糧艱選餘襯蓋糧範) 更多	-	2026-06-01