A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2030-01-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT04910386

/ Not yet recruiting临床2期

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

开始日期2027-06-01

申办/合作机构

四川思路康瑞药业有限公司

NCT07365306

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

开始日期2026-12-30

申办/合作机构

City of Hope National Medical Center

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100 项与盐酸吉西他滨相关的临床结果

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100 项与盐酸吉西他滨相关的转化医学

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100 项与盐酸吉西他滨相关的专利（医药）

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13,191

项与盐酸吉西他滨相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

作者: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Zhao, Angela ; Lotan, Yair

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

2026-03-01·Oncology and Therapy

Neoadjuvant Therapy in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer: Recent Progress, Challenges, and Future Directions in the Era of TAR-200 and Enfortumab Vedotin Plus Pembrolizumab

Review

作者: Buonerba, Carlo ; Di Lorenzo, Giuseppe ; Di Maio, Massimo

Cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy remains the standard of care for patients with nonmetastatic muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. However, many patients cannot receive cisplatin because of renal dysfunction, frailty, neuropathy, ototoxicity, or comorbidities, leaving an unmet need for effective cisplatin-free perioperative options. Single-arm phase 2 studies of neoadjuvant immune checkpoint inhibitors (ICIs) have shown encouraging pathologic complete response (pCR) rates in patients who are ineligible for cisplatin or who decline it, and randomized survival evidence has only recently begun to mature. Two conceptually distinct cisplatin-free paradigms are now shaping the field: (1) systemic intensification with perioperative enfortumab vedotin plus pembrolizumab, an antibody-drug conjugate (ADC) plus programmed death 1 (PD-1) inhibitor regimen supported by phase 3 data; and (2) bladder-centered intensification with TAR-200 (intravesical sustained-release gemcitabine) combined with systemic PD-1 blockade, which has demonstrated promising pathologic activity in early-phase studies but remains investigational in MIBC. This narrative review summarizes the evolving perioperative evidence base across traditional NAC, neoadjuvant ICI monotherapy, ADC-ICI combinations, and locoregional drug delivery approaches; highlights key interpretive challenges including heterogeneous trial populations and endpoints and the limitations of cross-trial comparisons; and discusses future directions such as response-adapted escalation and de-escalation strategies using circulating tumor DNA and urinary tumor DNA. We present a conceptual framework for future prospective trials evaluating how systemic and bladder-centered strategies might be selected and sequenced, rather than definitive guidance for routine clinical practice.

2026-02-24·CURRENT TOPICS IN MEDICINAL CHEMISTRY

An Expedition of FDA-Approved Anticancer Drugs in 2024: Synthetic Routes, Mechanisms of Action, and Clinical Indications.

Article

作者: Kurmi, Balak Das ; Priya, Sakshi ; Soni, Reena ; Cherian, Issac V ; Kasana, Shivani ; Islam, Md Mustahidul ; Das, Km Supriya ; Patel, Preeti

The year 2024 witnessed significant advancements in cancer therapy, with the U.S. Food and Drug Administration (FDA) approving 56 anticancer drugs for various malignancies. These approvals encompass 36 organic small molecules and 20 macromolecular monoclonal antibody conjugates, each with distinct mechanisms of action targeting key oncogenic pathways. Among the small molecules, kinase inhibitors such as Ribociclib, Imatinib Mesylate, and Nilotinib Hydrochloride Dihydrate modulate critical signaling cascades, while antimetabolites like Fluorouracil and Pemetrexed Disodium disrupt nucleotide biosynthesis. Other classes include DNA-damaging agents (Mitomycin, Gemcitabine Hydrochloride), immune modulators (Pomalidomide, Lenalidomide), and hormonal antagonists (Abiraterone Acetate, Erleada). The macromolecular therapeutics primarily consist of monoclonal antibody-based agents, such as Keytruda, Tecentriq, and Imfinzi, which enhance immune checkpoint inhibition, and antibody-drug conjugates like Enhertu and Elahere, which deliver cytotoxic payloads with high specificity. This review systematically examines the chemical synthesis, mechanisms of action, and therapeutic indications of these FDAapproved agents, emphasizing their role in improving patient outcomes. By analyzing their structural frameworks and biological targets, we aim to provide insights into current trends in anticancer drug development and potential future directions.

1,356

项与盐酸吉西他滨相关的新闻（医药）

2026-04-13

·allsci.com

Revolution Medicines’ daraxonrasib nearly doubles OS in Phase III pancreatic cancer trial

Revolution Medicines (Nasdaq: RVMD) reported that its lead pipeline candidate, the RAS(ON) multi-selective inhibitor daraxonrasib, nearly doubled median overall survival (OS) versus chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), among the most pronounced survival separations recorded in a randomized pancreatic cancer trial. The RASolute 302 trial (NCT06625320) is a global, randomized, open-label Phase III study comparing daraxonrasib 300 mg orally once daily against investigator’s choice of cytotoxic chemotherapy in patients with previously treated metastatic PDAC, enrolling across a broad range of RAS variants. In the intent-to-treat population, daraxonrasib produced a median OS of 13.2 months versus 6.7 months for chemotherapy (HR 0.40, p<0.0001). The trial met both co-primary endpoints — progression-free survival (PFS) and OS in the RAS G12-mutant population — as well as all key secondary endpoints, including PFS and OS in the broader intent-to-treat population. The company stated that results from the first interim analysis are considered final. Numerical PFS data were not disclosed in the topline release. The safety summary was qualitative: daraxonrasib was described as generally well tolerated with no new safety signals identified. The 6.7-month control arm OS aligns with what has been observed historically in second-line PDAC chemotherapy, a setting where no targeted therapy has previously been approved for the dominant RAS-mutated population. More than 90% of PDAC patients harbor RAS mutations, predominantly G12D, G12V, and G12R, yet until now every approved targeted agent in this disease — olaparib for germline BRCA-mutated patients, pembrolizumab for the rare MSI-H subset, zenocutuzumab-zbco for NRG1-fusion tumors — collectively addresses fewer than 10% of patients. Daraxonrasib’s trial enrolled patients across that full RAS variant spectrum, including wild-type cases, making the breadth of the population studied a distinguishing feature of the program. Daraxonrasib is an oral, non-covalent RAS(ON) multi-selective inhibitor. It suppresses RAS signaling by blocking the interaction between the active, GTP-bound form of both wild-type and mutant RAS proteins and their downstream effectors. The approach differs from earlier allele-specific KRAS inhibitors, which target a single mutation such as G12C, and from indirect RAS pathway inhibitors such as MEK or RAF inhibitors. The non-covalent, multi-selective mechanism is designed to capture the range of G12 variants that collectively define the oncogenic landscape of PDAC, rather than restricting benefit to a single-allele subpopulation. The RAS inhibitor field has moved rapidly since the first approval of a direct KRAS inhibitor, sotorasib (Lumakras), for KRAS G12C-mutated non-small cell lung cancer in 2021, followed by adagrasib (Krazati). Both are covalent, allele-specific agents and have limited applicability in PDAC, where G12C is rare. Daraxonrasib’s design explicitly targets the more common G12D, G12V, and G12R variants that drive the overwhelming majority of pancreatic RAS-addicted tumors. Cross-trial comparisons are limited by differences in patient populations, prior therapy, and trial design, but the 0.40 hazard ratio reported in RASolute 302 is numerically distinct from what has been observed with cytotoxic regimens in this line of therapy. The oral once-daily dosing distinguishes daraxonrasib from the intravenous regimens that currently define second-line PDAC care — Onivyde plus 5-FU/leucovorin, gemcitabine plus nab-paclitaxel, and FOLFIRINOX variants — all of which require infusion infrastructure and clinic visits. That practical difference carries weight in a disease where performance status often deteriorates rapidly and quality of life was included as a secondary endpoint in RASolute 302. Revolution Medicines holds FDA Breakthrough Therapy Designation and Orphan Drug Designation for daraxonrasib in previously treated metastatic PDAC harboring G12 mutations, and the drug was selected for the FDA Commissioner’s National Priority Voucher pilot program. The company intends to submit a New Drug Application to the FDA under that voucher and to file with other global regulatory authorities. Data are also planned for presentation at the 2026 American Society of Clinical Oncology Annual Meeting, where full PFS figures, subgroup analyses, and detailed safety tables are expected to become available for independent evaluation. Beyond the second-line PDAC setting, Revolution Medicines has three additional Phase III registrational trials running in pancreatic cancer, including a first-line metastatic study evaluating daraxonrasib alone and in combination with gemcitabine plus nab-paclitaxel, and an adjuvant study in resected PDAC. A Phase III trial in RAS-mutated non-small cell lung cancer is also underway. The RASolute 302 readout is the first Phase III result from this program. The topline nature of the current disclosure means that several questions remain open before the full clinical picture can be assessed: the magnitude of PFS benefit, the consistency of OS results across RAS variant subgroups, the proportion of patients who crossed over at progression, and the granularity of adverse event rates by grade. Those details will determine how the data are interpreted by regulatory agencies and, if approved, how daraxonrasib is positioned relative to chemotherapy in clinical practice guidelines.

临床3期临床结果ASCO会议孤儿药突破性疗法

2026-04-09

·岗位小站 Pro

全球药企巨头礼来医疗：深耕百年，以人才筑就健康未来｜求职必看指南

点击蓝字关注我们走进名企—— 礼来医疗前言在医药健康行业，有这样一家企业——成立近150年，从首款动物胰岛素到全球领先的GLP-1药物，从美国印第安纳州的小药厂到全球市值第一的医药巨头，它始终以“研发改变生命”为初心，既承载着百年药企的厚重底蕴，也焕发着科技创新的蓬勃活力。它就是礼来医疗（Eli Lilly and Company），如今正持续深耕中国市场，为求职者提供兼具稳定性与发展性的职业舞台。一企业介绍礼来医疗成立于1876年5月10日，由药学家礼来上校创建，总部位于美国印第安纳州印第安纳波利斯市，是全球历史最悠久的制药企业之一，也是首个进入“万亿美元俱乐部”的医疗保健企业。历经近150年发展，礼来已形成覆盖研发、生产、销售全链条的全球化布局，在全球50多个国家开展药品临床试验，设有8个研发中心、13个生产基地，产品行销143个国家和地区。礼来与中国的渊源始于1918年，当年在上海设立首个海外代表处，1993年重新进入中国市场后，布局持续升级——在上海张江高科技园区建有全球研发中国总部和研发中心，在苏州设立独资制药企业（礼来苏州制药有限公司），并在全国数十个城市建立办事机构，目前在中国拥有员工近四千人，业务覆盖近四百个城市。未来十年，礼来计划扩展在华供应链产能，进一步夯实中国在其全球网络中的战略地位。二核心业务礼来始终以“发现和开发让生命更美好的药物”为使命，聚焦代谢健康、肿瘤、免疫、神经科学、骨骼健康五大核心领域，打造了丰富的产品管线，既有家喻户晓的经典药物，也有引领行业的创新疗法，其中多个产品成为全球“重磅炸弹”级药物。代谢健康领域作为礼来的核心增长板块，该领域以GLP-1双/三靶点技术构建绝对优势，代表性产品包括替尔泊肽（Tirzepatide），这是全球首创GLP-1/GIP双靶点激动剂，此外，礼来还布局了下一代管线，包括口服小分子GLP-1药物奥格列龙（Orforglipron）、GLP-1/GIP/GCG三靶点药物Retatrutide，同时，礼来的优泌林®、优泌乐®等胰岛素系列产品，多年来始终服务于糖尿病患者，奠定了其在代谢领域的领先地位。肿瘤领域礼来在肿瘤领域布局广泛，拥有多款针对性疗法，涵盖乳腺癌、胰腺癌、肺癌、罕见血液癌症等多个细分领域。代表性产品包括阿贝西利片（唯择®）、塞普替尼胶囊（睿妥®）、盐酸吉西他滨（健择®）等。免疫与神经科学领域免疫领域，礼来拥有米吉珠单抗注射液（安妥来利®）、巴瑞替尼片（艾乐明®）等产品，用于治疗银屑病、类风湿关节炎、重度斑秃等自身免疫性疾病，其中巴瑞替尼片还被用于新冠感染的辅助治疗，获得全球多个国家批准。神经科学领域，礼来的多奈单抗（记能达®）是靶向淀粉样蛋白的阿尔茨海默病治疗药物。其他核心领域在骨骼健康领域，礼来的特立帕肽注射液（复泰奥®）用于治疗骨质疏松症，为中老年群体提供骨骼健康保障；同时，礼来还生产抗生素、生长激素和动物保健品等，形成了多元化的产品矩阵。企业多岗热招，了解更多岗位资讯欢迎扫码咨询，为你竭诚答疑三企业优势在全球医药行业竞争中，礼来凭借难以复制的核心优势，长期保持领先地位，这些优势也为求职者提供了稳定且优质的职业发展环境。 01 研发创新壁垒礼来始终将研发作为核心竞争力，公司拥有全球领先的多肽药物合成、AI药物研发、生物制剂生产三大技术平台，其中AI平台可将研发周期缩短30%，长效多肽修饰技术使药物半衰期延长至每周一次，大幅提升患者用药便利性。目前，礼来拥有40+临床三期项目，覆盖代谢、肿瘤、自免、神经四大领域，形成“上市一代、临床一代、储备一代”的管线格局，3-5年的技术代差难以被同行逾越。 02 产能与供应链壁垒礼来在全球拥有完善的产能布局，在美国、欧洲、爱尔兰自建数百亿美元注射剂灌装线，全球80%的GLP-1产能集中于礼来与诺和诺德，形成绝对的产能优势。此外，礼来的多肽药物生产工艺复杂，良率与成本控制为独家机密，新进入者需5-8年才能追赶，进一步巩固了其供应链优势。 03 商业化与品牌壁垒礼来拥有覆盖143个国家的渠道网络，与90%的全球TOP100药房深度合作，其产品在全球范围内的医保覆盖率达90%以上，确保药物能够触达更多患者。近150年的品牌积淀，让礼来在医生和患者中拥有极高的信任度，品牌影响力稳居全球医药行业前列。 04 人才与文化壁垒公司注重多元包容，鼓励员工敢说、敢做、敢挑战，同时通过完善的激励机制和关怀体系，提升员工归属感，形成了兼具凝聚力与创新力的企业文化，这也是其能够吸引和留住顶尖人才的核心原因之一。四福利保障作为全球顶尖药企，礼来的福利保障体系兼顾“物质激励”与“人文关怀”，贴合员工不同人生阶段的需求，其福利水平在医药行业处于领先地位，具体可分为四大板块：一、薪酬激励礼来实行具有行业竞争力的薪酬体系，且代表层面晋升一次title，底薪涨幅可达20%-25%，此外，礼来推行全员持股政策。二、假期福利年假约20天，另设有10天公司内部假期、10天关怀年假，还有3天“小暑假”，全年假期总量远超行业平均水平。同时，部分岗位支持每周2天居家办公，兼顾工作与生活平衡；员工可享受法定节假日、婚假、产假等全套假期，其中产假按国家规定足额发放薪资，且有额外的产假补贴。三、其他福利为员工缴纳足额五险一金，额外缴纳10%补充公积金，同时为员工及子女购买商业保险，覆盖门诊、住院、重疾等多个场景，提供年度体检、节日礼金、生日福利、通勤补贴、餐补等基础福利，同时设有员工食堂、健身房、下午茶等，改善员工办公体验。此外，员工可享受内部购药优惠，部分药物可免费领取，切实惠及员工及家属；针对优秀员工，公司还提供海外培训、国际交换等机会，拓宽员工视野。五真实口碑兼顾正面与负面，给求职者最真实的参考：一、正面口碑： ·薪酬福利优质：礼来薪资水平高于同行业药企，年终奖丰厚、股票激励有吸引力，福利体系完善，尤其是补充公积金、子女商业险等，细节关怀到位。 ·平台资源雄厚：作为全球巨头，礼来拥有完善的研发、生产、销售体系，员工可接触到行业顶尖技术和资源，尤其是研发岗位，能够参与全球前沿药物的研发项目，个人专业能力提升迅速；销售岗位则拥有成熟的渠道网络，工作开展更顺畅。二、负面槽点： ·奖金制度存在争议：近年来礼来奖金制度进行改革，奖金分为全国业绩、大区排名、个人行为、年度奖金四部分，其中个人行为评定标准不够量化，主观性较强。 ·部分岗位压力较大：研发岗位因项目进度紧、临床试验要求高，加班较为频繁，且考核严格，销售岗位受市场竞争影响，业绩考核压力较大，尤其在市场环境不佳时，业绩达成难度增加，收入波动较大。企业近期热招岗位上海、苏州、南昌、北京、上海、杭州、广州、合肥等多个城市均有多个岗位同步开放。一、研发类：高级 / 资深 QC 微生物分析师、生物功能学验证科学家、临床研究项目经理二、生产与制造类：设备助理工程师三、市场与销售类：医药推广、医学信息沟通专员四、职能支持类：供应链高级经理了解更多岗位资讯/岗位内推/职业规划扫码领取求职大礼包发送简历，免费评估资质，定位求职方向欢迎咨询，为你竭诚答疑解惑

上市批准引进/卖出

2026-04-09

·ioncology

国际视野丨从病理完全缓解到临床完全缓解，更新MIBC患者获益评估及保膀胱方案

点击上方蓝字关注我们编者按：随着治疗策略的快速发展，肌层浸润性膀胱癌（MIBC）的治疗模式正从“一刀切”的根治性膀胱切除术，转向基于分子分型和患者状态的个体化、保膀胱策略。同时，疗效评估也从单一的病理完全缓解向整合了影像学、尿液细胞学及活检的临床完全缓解，有望助力患者在根治肿瘤与保留器官功能之间找到最佳平衡。肿瘤瞭望-泌尿时讯特别整理相关内容，以飨读者。亮点抢先看 1 MIBC患者处于治疗和疾病疗效监测领域重大进展的前沿，这对根治性膀胱切除术的模式转变具有重要意义。 2 个性化循环肿瘤DNA（ctDNA）检测是迄今为止最可靠的生物标志物，具有很高的预后价值，并能预测辅助免疫检查点抑制剂的疗效；ctDNA和尿液肿瘤DNA（utDNA）是整合到新辅助治疗方案的理想候选指标，有望实现膀胱保留。 3 对于接受围手术期治疗的特定保膀胱患者，需要修订临床完全缓解（cCR）和其他终点的定义。系统治疗进展近年来，尿路上皮癌的系统治疗迎来突破性进展，其意义远超生存期的延长，更在于重新定义了肿瘤控制与器官保留的可能性。包括抗体偶联药物（ADC）和免疫检查点抑制剂的创新疗法，正在改写晚期患者的治疗格局。针对肌层浸润性膀胱癌（MIBC）这一群体，基于KEYNOTE-905/EV-303试验数据，美国FDA已批准维恩妥尤单抗联合帕博利珠单抗作为不耐受顺铂患者的围手术期标准方案。而对于顺铂适用人群，NIAGARA试验证实度伐利尤单抗联合吉西他滨/顺铂的新辅助化疗组合可显著改善无病生存期，该方案已获FDA及EMA批准。这标志着MIBC患者能够根据肾功能及体能状态选择最优策略，在根治肿瘤的同时保留膀胱功能，实现从"一刀切"到"量体裁衣"的治疗转变。利用微小残留病灶监测优化治疗策略在MIBC的治疗探索中，ctDNA与utDNA监测正成为优化治疗决策的关键指标，为全身治疗反应评估及微小残留病灶（MRD）监测提供了全新视角。Aarhus研究组已系统证实，在新辅助化疗联合根治性膀胱切除术的全程管理中，连续ctDNA监测具备显著的预后预测价值。此后，基于辅助治疗IMvigor010试验的深入剖析，1级循证医学证据进一步证实：对于根治性膀胱切除术后ctDNA阳性的患者，实施个体化的ctDNA指导阿替利珠单抗辅助治疗，可带来明确获益——该试验数据显示，ctDNA阳性患者的无病生存期风险比（HR）为0.66，总生存期HR为0.59；同时，持续ctDNA阴性的患者，无需辅助治疗即可实现良好生存，凸显了精准分层治疗的优势。此外，CheckMate-274、NIAGARA等聚焦个体化与MRD指导的辅助及围手术期临床试验，持续丰富着这一领域的临床证据。NIAGARA试验揭示，基线ctDNA状态与新辅助治疗后的ctDNA清除率，均能有效预测无事件生存期（EFS）；且ctDNA检测结果与膀胱切除术前未达病理完全缓解（pCR）高度相关，并可预测术后无病生存期。SunRISe-4试验则聚焦ctDNA与尿液DNA（utDNA）的互补性，指出新辅助治疗后，utDNA状态及清除率与pCR相关，而ctDNA虽与pCR无直接关联；研究也证实，ctDNA可精准预测无复发生存期，为临床监测提供了多元参考。随着新型疗法持续突破，患者生存获益显著提升，pCR率也迎来飞跃——EV-303意向治疗人群的pCR率高达57%。在此背景下，患者愈发关注生活质量与膀胱功能的保留，开始对根治性膀胱切除术的必要性提出质疑，尤其是在术前已实现深度缓解的情况下。这一观念转变，既是治疗成效的有力印证，也折射出患者对生活质量与器官功能保留的诉求。治疗终点评估指标的转变当前，临床试验的终点设定正悄然发生转变——从病理完全缓解（pCR）向临床完全缓解（cCR）倾斜，核心目标直指缓解适应性治疗策略，助力部分患者免于根治性膀胱切除术。从初步试验结果来看，这一探索结果令人鼓舞：部分患者延迟膀胱切除术具备可行性，相关试验不仅验证了治疗的安全性，更呈现出颇具潜力的无转移生存期数据，尤其在新辅助治疗后联合维持性免疫检查点抑制剂的研究，优势更为凸显。为统一cCR定义，并优化新型、基于疗效的膀胱保留试验的终点指标，米兰多方利益相关者共识会议重磅提出系列关键建议。具体而言，cCR的判定应包括影像学完全缓解、尿细胞学阴性及活检阴性三大标准；而无事件生存期（EFS）的范畴则应覆盖各类肿瘤复发，包括高级别、非肌层浸润性复发——这类复发在现有疗效导向型膀胱保留试验中占比极高。尤为关键的是，虽然一致认为cCR可作为新辅助治疗阶段新型研究药物的可靠筛选生物标志物，但EFS被强烈推荐为后期和注册试验的合适终点，因为它能够反映膀胱内复发、挽救性膀胱切除术的必要性以及远处复发。 MRD服务于保膀胱策略回溯2024年12月共识会议召开之际，IMvigor011研究及多项聚焦MIBC患者MRD的试验，关键成果尚未公布。时至今日，液体活检技术的应用持续拓展，其价值早已突破单纯的预后评估，更成为调整治疗方案的支持工具，包括精准筛选出可安全接受膀胱保留治疗的患者群体。从现有数据来看，基于肿瘤信息的ctDNA检测，已然成为极具临床价值的风险分层利器，尤其在新辅助治疗与膀胱切除术后的场景中表现突出。与此同时，围绕新辅助、辅助免疫检查点抑制剂治疗的选择，以及早期捕捉MRD为目标的连续监测，相关研究数据正不断积累。当下，一批关键研究正稳步推进：MODERN试验聚焦膀胱切除术后，依据MRD状态制定降阶或升级治疗策略，进一步验证个性化ctDNA监测的临床有效性；ARCHER试验则深入探索放化疗后ctDNA清除模式，挖掘其作为治疗反应与复发预测标志物的潜力，此外还有众多研究正蓄势待发。在MIBC患者的保膀胱领域，三联疗法仍然是公认的标准治疗方案，为新兴的以系统治疗为主导的保膀胱策略树立了核心参照标杆。目前，多项关键3期临床试验正聚焦免疫检查点抑制剂联合标准放化疗或创新方案的疗效验证。截至目前，多数试验结果仍未揭晓，仅SunRISe-2临床试验率先披露阶段性动态——该试验对比吉西他滨膀胱灌注系统（Gem-iDRS，原TAR-200）联合Cetrelimab与放化疗的疗效，因膀胱完整患者的无事件生存期未获改善，在中期分析后遗憾终止，完整数据预计于2026年公布。而其他试验的初步数据也进一步印证，ctDNA在三联疗法中的预后评估价值。展望未来总体来看，ctDNA能否替代传统横断面影像学检查，及其能否精准指导强化治疗、动态调整围手术期方案，而非固守既定辅助治疗路径（如辅助度伐利尤单抗、维恩妥尤单抗联合帕博利珠单抗），目前仍存在不确定性。这种不确定性对于根据患者反应调整的保膀胱治疗方案尤为重要，因为漏诊膀胱复发会带来严重的临床后果。值得关注的是，SunRISe-4试验针对拒绝或不耐受顺铂的患者，对比了新辅助TAR-200+Cetrelimab方案和Cetrelimab单药在膀胱切除术前的疗效，结果显示：ctDNA对pCR的预测效能有限，而新辅助治疗后utDNA水平及清除率与pCR紧密相关。这意味着，在联合MRD评估时，尿液标志物如utDNA的整合势在必行。依据米兰共识，ctDNA或utDNA检测是否纳入未来cCR定义的更新，尚存争议，相关指南更新或即将落地。总之，MIBC患者治疗模式的革新，不仅体现治疗手段的进步上，也同步体现在疾病监测与疗效定义的突破上。尽管这一进程令患者满怀期待，也远超既往预期，但如何精进新技术应用、实现与新方案的高效融合，以及如何为患者提供全面信息以助力其做出安全、理性的决策，仍是亟待破解的课题。参考文献上下滑动查看更多内容 [1]Galsky MD, Ballas L, Kamat AM. Muscle-invasive bladder cancer: a watershed moment. J Clin Oncol. 2025;43(27):3041-3051. [2]Vulsteke C, Kaimakliotis H, Danchaivijitr P, et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: the phase III KEYNOTE-905 study. Ann Oncol. 2025;36(suppl 2):S1763. [3]Powles T, Catto JWF, Galsky MD, et al; NIAGARA Investigators. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391(19):1773-1786. [4]U.S. Food and Drug Administration. FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. FDA.gov. November 21, 2025. Accessed December 22, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer [5]U.S. Food and Drug Administration. FDA approves durvalumab for muscle invasive bladder cancer. FDA.gov. March 28, 2025. Accessed December 22, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer [6]Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019;37(18):1547-1557. [7]Powles T, Assaf ZJ, Davarpanah N, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021;595(7867):432-437. [8]Powles T, Kann AG, Castellano D, et al; IMvigor011 Investigators. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med. 2025;393(24):2395-2408. [9]Galsky MD, Gschwend JE, Milowsky MI, et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol. 2025;37(1):69-78. [10]Powles T, Van Der Heijden MS, Wang Y, et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. J Clin Oncol. 2025;43:16s (suppl; abstr 4503). [11]Necchi A, Guerrero-Ramos F, Crispen PL, et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC: primary analysis and biomarker results of SunRISe-4. J Clin Oncol. Published online December 3, 2025. [12]Galsky MD, Daneshmand S, Izadmehr S, et al. Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial. Nat Med. 2023;29(11):2825-2834. [13]Geynisman DM, Abbosh PH, Ross E, et al. Phase II trial of risk-enabled therapy after neoadjuvant chemotherapy for muscle-invasive bladder cancer (RETAIN 1). J Clin Oncol. 2025;43(9):1113-1122. [14]Ghatalia P, Ross E, Zibelman M, et al. A phase 2 trial of risk enabled therapy after neoadjuvant chemo-immunotherapy for muscle-invasive bladder cancer (RETAIN-2). J Clin Oncol. 2025;43:5s (suppl; abstr 815). [15]Necchi A, Galsky MD, Dizman N, et al. End points for the next-generation bladder-sparing perioperative trials for patients with muscle-invasive bladder cancer. J Clin Oncol. 2025;43(32):3536-3544. [16]Johnson & Johnson. Johnson & Johnson statement on the SunRISe-2 study. October 7, 2024. Accessed December 31, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-sunrise-2-study [17]Raizenne B, Koshkin VS, Dufault S, et al. Prognostic utility of ctDNA before and after trimodality therapy (TMT) for muscle invasive bladder cancer. J Clin Oncol. 2025;43:16s (suppl; abstr 4578). （来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

抗体药物偶联物申请上市

100 项与盐酸吉西他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01155	盐酸吉西他滨	L01BC05	DB00441

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	Janssen Biotech, Inc.	2025-09-09
局部晚期非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
局部晚期胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
复发性卵巢癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
尿路上皮癌	日本	Eli Lilly & Co.	2008-11-25
膀胱癌	巴西	Libbs Farmacêutica Ltda.	2008-05-26
胆道癌	日本	Eli Lilly & Co.	2001-08-31
淋巴瘤	日本	Eli Lilly & Co.	2001-08-31
卵巢癌	日本	Eli Lilly & Co.	2001-08-31
乳腺癌	美国	Eli Lilly & Co.	1996-05-15
转移性乳腺癌	美国	Eli Lilly & Co.	1996-05-15
非小细胞肺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺腺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺癌	美国	Eli Lilly & Co.	1996-05-15

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
晚期胆道癌	临床3期	中国台湾	因华生技制药股份有限公司	2025-07-01
复发性膀胱癌	临床3期	美国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	中国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	日本	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	阿根廷	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	比利时	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	巴西	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	法国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	德国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	意大利	Janssen Research & Development LLC	2024-04-09

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临床结果

适应症

分期

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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


ESMO_SRC2026	N/A	平滑肌肉瘤二线	108	Trabectedin	糧選淵襯餘鬱鏇觸願繭(網獵齋簾壓餘觸積夢憲) = 廠糧積遞網製獵網膚簾獵鹹鑰遞夢襯簾鹽壓選 (艱遞網窪醖憲夢鏇鬱衊, 5.5 ~ 15.2) 更多	积极	2026-03-09
				gemcitabine-based chemotherapy	糧選淵襯餘鬱鏇觸願繭(網獵齋簾壓餘觸積夢憲) = 夢範簾繭積壓構醖鬱鹽獵鹹鑰遞夢襯簾鹽壓選 (艱遞網窪醖憲夢鏇鬱衊, 3.8 ~ 6.4) 更多
ESMO_SRC2026	N/A	软骨肉瘤	10	Gemcitabine 1000 mg/m2 plus Oxaliplatin 100 mg/m2	壓衊膚襯蓋築選糧壓鏇(鏇醖鹹鹹構築夢鬱顧顧) = Treatment was generally well tolerated, with limited grade 3 toxicity and one case of grade 5 thrombotic microangiopathy-associated to gemcitabine 艱襯壓鑰選齋艱觸鹽簾 (膚鏇醖範顧艱膚醖襯鹽 )	积极	2026-03-09
ESMO_SRC2026	N/A	血管周围上皮样细胞肿瘤	3	sirolimus + exemestane + gemcitabine	鏇繭鬱遞夢膚簾憲衊鏇(顧蓋齋齋製獵繭繭膚構) = 遞鹹觸夢鑰衊簾壓鏇衊鑰壓構醖鹽範憲鏇壓壓 (範遞襯構鬱膚衊夢憲衊 ) 更多	积极	2026-03-09
ESMO_SRC2026	N/A	平滑肌肉瘤	336	Gemcitabine combined with docetaxel	鏇選築顧夢夢齋壓製鏇(繭鹹繭餘鹽選夢範夢鑰) = 鬱繭構鬱夢鬱鏇範鹹繭築鹽廠鹽壓窪鹹鏇鏇憲 (網獵夢憲繭網願鏇簾選 ) 更多	积极	2026-03-09
NCT04179162 (ALLIANCE A032303, ASCO_GU2026)	临床1/2期	复发性膀胱癌	52	Gemcitabine + BCG	選選獵糧鑰積壓鏇淵齋(夢選選鹹鬱獵簾網淵壓) = 繭繭襯繭憲襯餘鬱願繭鹹廠醖夢鬱蓋鏇齋蓋繭 (憲淵願淵廠選糧簾選淵 ) 更多	积极	2026-02-26
ASCO_GU2026	N/A	肌层浸润性膀胱癌新辅助	517	Gemcitabine 800 mg/m2	鹹鬱選艱糧範餘襯餘觸(醖窪衊網膚廠衊顧淵襯): P-Value = 0.012 更多	积极	2026-02-26
				Gemcitabine 1000 mg/m2
ASCO_GU2026	N/A	非肌层浸润性膀胱肿瘤	133	BCG	製鹹廠淵顧齋窪鬱齋憲(繭憲窪醖廠繭顧廠積蓋) = 積範淵廠壓壓窪壓獵遞蓋醖鑰膚淵遞窪糧醖糧 (網構鏇鏇壓遞餘鬱鹽鏇 ) 更多	不佳	2026-02-26
				sequential gemcitabine and docetaxel (Gem/Doce)	製鹹廠淵顧齋窪鬱齋憲(繭憲窪醖廠繭顧廠積蓋) = 襯範衊鑰襯繭廠鬱壓顧蓋醖鑰膚淵遞窪糧醖糧 (網構鏇鏇壓遞餘鬱鹽鏇 ) 更多
ASCO_GU2026	N/A	肌层浸润性膀胱癌	98	Cisplatin	蓋餘壓醖夢鏇憲鏇齋鑰(積糧淵膚壓襯壓願製範) = 廠鬱鹹構範醖鏇壓鹹艱製夢廠糧獵艱壓淵蓋鬱 (顧餘繭鏇齋顧網壓遞繭 ) 更多	积极	2026-02-26
				5-FU+MMC	蓋餘壓醖夢鏇憲鏇齋鑰(積糧淵膚壓襯壓願製範) = 淵齋鏇獵選蓋鑰壓衊廠製夢廠糧獵艱壓淵蓋鬱 (顧餘繭鏇齋顧網壓遞繭 ) 更多
NCT04628767 (EA8192, ASCO_GU2026)	临床2期	肾盂和输尿管尿路上皮癌新辅助	30	Gemcitabine/Durvalumab	蓋選夢鹹築襯鏇鹹憲醖(膚壓構膚餘廠鏇鏇鑰範) = 積糧顧願淵鏇選廠鹹襯願鬱獵鹽遞範築繭廠鏇 (壓願鹹觸選觸簾膚餘鏇, 3.0 ~ 25.2) 更多	积极	2026-02-26
NCT03366766 (CTgov)	临床2期	非小细胞肺癌Ⅰ期 \| 可切除非小细胞肺癌 \| 非小细胞肺癌IIIA期 ... 更多	14	Nivolumab+cisplatin+Pemetrexed Disodium (Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium))	蓋襯積窪醖網選觸齋觸 = 遞壓築鹽鬱鑰淵壓獵壓艱構範構遞窪鬱鹹構選 (鹽窪鹹鬱憲齋觸築艱壓, 範憲選築蓋製積淵築醖 ~ 簾廠膚淵網構遞餘夢鏇) 更多	-	2026-02-20
				nivolumab+Gemcitabine Hydrochloride (Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride))	鏇積廠壓繭鏇簾鹽遞鏇 = 鹹廠襯齋襯鹽膚廠廠網艱網鏇鬱願網艱夢繭衊 (窪願憲鏇膚淵遞鹹襯餘, 衊獵製蓋顧壓鬱鹽網繭 ~ 願網範鬱壓齋蓋鹹網醖)