Phase II Clinical Study of Digoxin Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy

The goal of this clinical trial is to learn about efficacy of digoxin in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

开始日期2025-08-01

申办/合作机构

复旦大学

NCT07011576

/ Not yet recruiting临床2期

A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
* Evaluate the safety of the combination of fruquintinib + FOLFIRI

开始日期2025-07-01

申办/合作机构

SCRI Development Innovations, LLC

[+1]

NCT06973421

/ Not yet recruiting临床2期IIT

Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.

开始日期2025-07-01

申办/合作机构

复旦大学

100 项与呋喹替尼相关的临床结果

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100 项与呋喹替尼相关的转化医学

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100 项与呋喹替尼相关的专利（医药）

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238

项与呋喹替尼相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

2025-12-31·Human Vaccines & Immunotherapeutics

Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report

Article

作者: Qian, Xiaoping ; Li, Li ; Zhang, Qun

In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.

2025-08-01·Translational Oncology

FRESCO–2 trial and fruquintinib: A clearer picture of the control arm

Article

作者: Ranganathan, Sruthi ; Olivier, Timothée ; Prasad, Vinay ; Haslam, Alyson

Though vascular endothelial growth factor receptor (VEGFR)-targeting drugs have been approved in the past and are known for their potential off-site action, fruquintinib is a possible new, specific inhibitor of VEGFR-1, 2, and 3. The US Food and Drug Administration (FDA) recently approved fruquintinib based on the FRESCO-2 trial results. However, the FRESCO-2 trial is potentially problematic given the suboptimal choice of placebo in the trial, and the poor cost-effectiveness of fruquintinib. Firstly, we argue that fruquintinib should have been tested against regorafenib, and only offered a moderate benefit despite being tested against a suboptimal placebo. Secondly, fruquintinib is likely cost ineffective (measured in quality-adjusted life years (QALY)), with a crude estimation placing its value over a million USD per QALY. Lastly, we show that the use of a suboptimal placebo is unfortunately not new.

763

项与呋喹替尼相关的新闻（医药）

2025-06-23

·FierceBiotech

Exelixis\' blockbuster hopeful beats Bayer drug in pivotal cancer trial, sending stock higher

Investors sent Exelixis’ share price up 12% to about $45 on Monday.\n A combination featuring Exelixis’ experimental drug zanzalintinib has beaten Bayer’s gastrointestinal cancer med Stivarga in a phase 3 trial. The overall survival win moves Exelixis a step closer to its ambition of turning the oral tyrosine kinase inhibitor into a $5 billion-a-year product.Exelixis is developing zanzalintinib as the successor to its flagship oncology medicine Cabometyx. By improving attributes including pharmacokinetic half-life, the company has designed a molecule that it believes can win approval in a range of diseases and blast past Cabometyx’s peak sales. The phase 3 colorectal cancer trial was a key early proving ground for zanzalintinib.Investigators randomized 901 patients to receive Stivarga or zanzalintinib in combination with Roche’s checkpoint inhibitor Tecentriq. Overall survival in previously treated non-microsatellite instability-high metastatic colorectal cancer was significantly longer on the combination than on Stivarga.William Blair analysts said in a note to investors that the hit on the trial’s co-primary endpoint ensures a “meaningful commercial opportunity for the budding franchise.” The patient population covered by the endpoint represents the largest commercial opportunity open to zanzalintinib, according to analysts, who estimated risk-adjusted U.S. peak sales of $875 million. The analysts will be looking out for relative and absolute risk reduction when the full results are shared, because “these metrics could help us ascertain the clinical meaningfulness of the survival benefit.” But the available results are positive, leading investors to send Exelixis’ share price up 12% to about $45 on Monday.Exelixis will, however, need to rack up more clinical wins to deliver its major vision for zanzalintinib. The biotech expects GI cancers, including colorectal tumors, to account for 45% of the $5 billion in sales it hopes to generate in 2033. GI cancers accounted for 10% of Cabometyx sales last year, making the indications central to Exelixis’ ambitions to improve on the $1.8 billion generated by its current product.The biotech’s pursuit of the phase 3 colorectal cancer population could put it in competition with drugs including Amgen’s Lumakras, Bayer’s Stivarga, Taiho Oncology’s Lonsurf and Takeda’s Fruzaqla.

$Exelixis\' blockbuster hopeful beats Bayer drug in pivotal cancer trial, sending stock higher$

临床3期临床结果抗体药物偶联物

2025-06-23

·药事纵横

瀚合瑞：提供从立项到获批的全流程药学CRO服务 | 7thCMC-China优质推荐

上海瀚合瑞医药科技有限公司：提供制剂项目从立项到获批的全流程药学CRO服务，具备经验丰富的的固体制剂、液体制剂和半固体制剂研发团队，以及完备的工艺和分析研发设备。截至目前，团队已完成近200个仿制药和多个创新药制剂研发服务，多个仿制药项目取得国内首仿或前三仿。上海瀚合瑞医药科技有限公司隶属于天津臻诺医药集团，集团下设上海、天津2大CMC研发中心，2大临床研究中心及临床数据统计中心，以及1家原料生产基地，拥有20多家战略合作原料药和制剂生产基地，员工人数超600人，可为客户提供原料药和制剂产品从项目立项、药学研究、临床研究、委托加工、注册申报到MAH产品运营全生命周期一站式服务。集团技术服务平台01 制剂技术平台● 固体制剂、注射剂、外用制剂全流程开发● 难溶性药物给药技术● 固体分散体技术● 高难度复方制剂开发平台● MAH合作/品种转让02 原料技术平台● 仿制及创新原料药CMC研究● 产品定制研发和生产服务（CDMO）● 含氟中间体和原料药平台● 不对称合成、生物酶催化、连续化等技术应用03 临床技术平台 ● 临床药代动力学● 生物等效性● 临床实验方案设计及研究运营、覆盖Ⅰ-Ⅳ期及真实世界● 分析检测服务重点项目推荐奥匹卡朋胶囊01规格：25mg、50mg适应症：左旋多巴/卡比多巴的辅助治疗，适用于帕金森病(PD)的“off”期发作研发进展：原料药&制剂联合开发，中试阶段多替诺雷片02规格：0.5mg、1mg、2mg适应症：痛风，高尿酸血症研发进展：原料药&制剂联合开发，验证批阶段布地奈德肠溶胶囊03规格：4mg适应症：具有进展风险的原发性IgA肾病成人患者研发进展：小试阶段富马酸依美斯汀缓释胶囊04规格：1mg、2mg适应症：过敏性鼻炎和荨麻疹研发进展：小试阶段盐酸米安色林片05规格：10mg，30mg适应症：治疗的各型抑郁症患者，能解除其抑郁症状研发进展：小试阶段西吡氯铵含片06规格：2mg适应症：用于急性、亚急性咽炎，牙龈炎研发进展：小试阶段地喹氯铵含片07规格：0.25mg适应症：用于急、慢性咽喉炎，口腔黏膜溃疡、齿龈炎研发进展：小试阶段苯磺酸美洛加巴林片/口崩片08规格：2.5mg、5mg、10mg、15mg适应症：糖尿病性周围神经病理性疼痛研发进展：小试阶段乌帕替尼缓释片&口服溶液09规格：片剂：15mg口服溶液：1mg/ml适应症：（片剂）特应性皮炎、类风湿关节炎、银屑病关节炎、溃疡性结肠炎等（口服溶液）2岁及以上患者银屑病关节炎、幼年特发性关节炎研发进展：验证批阶段巴瑞替尼片10规格：2mg、4mg适应症：类风湿关节炎、斑秃、特应性皮炎等研发进展：验证批阶段非奈利酮片11规格：10mg、20mg适应症：二型糖尿病相关的慢性肾病研发进展：原料药&制剂联合开发，审评中盐酸氮卓斯汀鼻喷雾剂12规格：10ml:10mg适应症：过敏性鼻炎研发进展：小试阶段非那雄胺喷雾剂13规格：2.275mg/ml适应症：用于 18 至 41 岁患有轻度至中度脱发（雄激素性脱发）的成年男性的局部治疗，以促进头发生长研发进展：小试阶段玛巴洛沙韦片/干混悬14规格：片剂：20mg、40mg干混悬剂：2mg/ml适应症：甲型和乙型流感研发进展：原料药&制剂联合开发，小试阶段醋酸地非法林注射液15规格：50μg/ml适应症：接受血液透析的患者，治疗慢性肾脏病相关的中度至重度瘙痒（CKD-aP）研发进展：中试阶段注射用西维来司他钠16规格：100mg适应症：用于改善全身性炎症反应综合征的急性肺损伤/急性呼吸窘迫综合征研发进展：小试阶段注射用氨曲南阿维巴坦钠17规格：1.5 g/0.5 g适应症：用于治疗复杂盆腔感染（cIAI）、复杂尿路感染（cUTI）、医院获得性肺炎（HAP）/呼吸机相关肺炎（VAP）等研发进展：小试阶段注射用盐酸依拉环素18规格：50mg适应症：适用于治疗成人复杂性腹腔感染（cIAI）研发进展：小试阶段依达拉奉右莰醇注射用浓溶液19规格：5ml:依达拉奉10mg与右莰醇2.5mg适应症：用于改善急性缺血性脑卒中所致的神经症状、日常生活活动能力和功能障碍研发进展：验证批阶段苹果酸奈诺沙星氯化钠注射液20规格：250mll:苹果酸奈诺沙星0.5g与氯化钠 2.25g适应症：成人社区获得性肺炎研发进展：待申报注射用磷酸左奥硝唑酯二钠21规格：0.125g、0.5g、1g适应症：肠道和肝脏严重的阿米巴病、敏感厌氧菌感染引起的手术后感染等研发进展：中试阶段甲苯磺酸奥马环素片&注射用甲苯磺酸奥马环素22规格：片剂150mg、注射剂100mg适应症：社区获得性细菌性肺炎感染、急性细菌性皮肤和皮肤结构感染研发进展：待申报注射用亚胺西瑞23规格：1.25g（亚胺培南500mg+西司他丁500mg+瑞来巴坦250mg）适应症：成人医院内获得性细菌性肺炎和呼吸机相关性细菌性肺炎、复杂性尿路感染、复杂性腹腔内感染研发进展：小试阶段呋喹替尼胶囊24规格：1mg、5mg适应症：结直肠癌研发进展：原料药&制剂联合开发，小试阶段阿帕他胺片25规格：60mg适应症：非转移性去势抵抗性前列腺癌及转移性去势敏感性的前列腺癌研发进展：原料药&制剂联合开发，审评中注射用卡非佐米26规格：60mg适应症：难治性多发性骨髓瘤研发进展：原料药&制剂联合申报，审评中阿贝西利片27规格：50mg、100mg、150mg适应症：早期乳腺癌；局部晚期或转移性乳腺癌研发进展：原料药&制剂联合开发，中试阶段妥卡替尼片28规格：50mg、150mg适应症：乳腺癌研发进展：原料药&制剂联合开发，中试阶段注射用盐酸美法仑29规格：50mg适应症：多发性骨髓瘤研发进展：中试阶段部分已有开发经验制剂品种联系我们周女士 13306586060嵇女士 15706844213张文静 15262236582大会详情 /CMC-CHINA点击下方图片了解更多▼

临床结果申请上市上市批准

2025-06-22

·生物制药小编

解锁创新药出海密码：四大主流模式对比，为企业国际化把脉

“出海”成为我国生物医药产业加速发展的重要策略。随着政策环境利好和企业研发实力增强，本土创新药企加速出海步伐，探索形成了自主出海、联手出海、借船出海、NewCo等多样化模式。本文对创新药出海模式进行对比分析，为企业选择出海路径提供参考和建议。一、创新药出海热潮与海外医药市场相比较，我国本土支付能力和定价空间有限，企业利润回报相对较少，倒逼企业寻求海外市场盈利空间。同时，我国创新药企自主研发实力逐渐与国际领先水平接轨，截至目前，我国创新药临床试验和上市数量稳居全球第二，CAR-T、ADC、siRNA以及PD-1/PD-L1等尖端领域表现亮眼，超30款创新药成功出海，创新药产业格局从“输入”转变为“输出”。在这一过程中，本土药企从战略布局、资本实力及海外商业化运营能力等多方面综合考虑，探索形成了自主出海、联手出海、借船出海、NewCo等多样化模式，全面走向全球市场。表1 2024年超十亿美元出海的国产创新药榜单表格信息来源：北国咨根据公开资料整理二、创新药出海模式表2 出海模式比较表格信息来源：根据公开信息整理，北国咨绘制（一）自主出海自主出海是指国内药企自主开拓国际市场，在海外开展临床试验和提交新药上市申请，自主搭建商业化团队进行海外销售，适合资金实力雄厚、研发能力强且拥有丰富海外运营和风险管理经验的大型药企。2019年，百济神州自主研发的BTK抑制剂泽布替尼以“突破性疗法”成功获得FDA批准上市，实现本土新药自主出海“零的突破”。2023年泽布替尼全年收入首次突破10亿美元大关，成为首款国产“重磅炸弹”药物，为我国创新药自主出海树立标杆。优势：企业能够独立掌握海外研发进度，独享商业化运营收益，提高本土创新药的国际话语权和自主权。随着中国药企研发创新能力提升以及对海外市场重视程度加强，自主国际临床、自主商业化将逐渐成为更多药企的首选。劣势：企业面临资金回流长周期、国际运营高难度、国际监管法规不熟悉等沉没成本和失败风险。如信达生物信迪利单抗、万春药业普那布林、君实生物特瑞普利单抗由于缺少美国患者临床试验数据、不符合美国药品监管要求等导致出海失利。（二）联手出海联手出海是指本土药企通过广泛筛选海外企业，与海外药企进行药物联合开发或销售渠道合作等，实现风险与利润共担，是介于自主出海与借船出海之间的一种折中方式。2023年，君实生物特瑞普利单抗（用于鼻咽癌治疗）在FDA批准上市，为创新药联手出海提供新突破。2021年，君实生物与Coherus达成特瑞普利单抗在美国和加拿大的联合开发和商业化合作，Coherus负责美国和加拿大的所有商业活动，君实生物将累计获得超11亿美元交易付款，共同加快创新药物全球注册上市。优势：企业借助海外临床经验丰富、商业化能力强且自身发展稳定的合作伙伴，可尽量避免被当地政策壁垒影响，降低出海风险。劣势：企业缺少一定的话语权和自主权，难以直接掌控海外市场销售策略与结果，且商业化收益受合作伙伴制约。（三）借船出海借船出海是本土药企目前采用最多的出海方式，本土药企自主进行药物早期研发，将临床及商业化等权益授权海外企业，按里程碑模式获得各阶段临床成果以及商业化销售分成，适合实力相对有限且国际化经验不足的企业。2023年11月，和黄医药呋喹替尼获得FDA批准上市，为创新药借船出海提供新样本。2023年，和黄医药与武田制药达成呋喹替尼全球独家许可协议，武田制药获得在中国大陆、香港和澳门以外地区开发和商业化独家权利，和黄医药将累计获得总额11.3亿美元交易款。借助武田制药全球销售网络和资源，呋喹替尼快速打入国际市场。优势：此模式风险较小且相对灵活，本土企业获得海外引进方提供的市场资源、销售渠道和经验，并依靠首付款和里程碑费用缓解资金压力。劣势：本土药企失去产品研发和商业化运营自主权，面临海外监管机构质疑、临床试验数据缺乏、双方合作取消等诸多不可控风险导致出海受阻，复创医药、基石药业、诺诚建华、加科思等在出海过程中均被退回。（四）NewCo模式NewCo为本土创新药企提供新的国际化道路，本土药企与海外基金共同成立新公司，将特定管线资产的海外权益授权给新公司，邀请多方资本参与提供资金支持，并为投资人提供退出机制。2024年，恒瑞医药转变出海战略，将具有自主知识产权的GLP-1产品组合有偿许可给海外新公司Hercules，率先解锁NewCo新模式。Hercules是恒瑞医药与贝恩资本生命科学基金联合Atas Ventures、RTW资本等共同设立。恒瑞医药将三款GLP-1产品管线的海外开发、生产及商业化权力独家授权给Hercules，获得Hercules 19.9%的股权和累计高达57亿美元的里程碑款，出海速度明显加快。优势：企业通过资本注入、海外授权和股权合作，获得资金支持和海外市场权益，降低商业化运营风险。海外引进方专注核心管线研发，可提高产品获批上市的成功率。劣势：本土企业面临着如何挑选合作伙伴、评估资产价值、融资并购与上市以及国际监管等难题。三、创新药出海模式选择相关建议当前，创新药寻求海外市场趋势显著且出海路径日益多元化，如何在出海浪潮下选择合适的策略和把握恰当的时机实现创新产品海外注册上市成为本土药企亟需解决的问题。一是聚焦前沿靶点和技术开展研究，以创新疗法、独特的分子结构或给药方式获得海外市场关注。注重提升创新产品质量，积极参与国际多中心临床试验，遵循国际药品研发标准和规范，确保数据质量和可接受性，支撑产品获批上市。二是企业准确判断自身核心竞争力、资本实力、海外市场商业化运营能力以及风险响应能力，选择合适的出海模式。授权方和引进方应把握自身中长期发展战略和市场发展前景，确保双方开展长期授权合作。三是积极拓展国际市场，结合国家战略，将目光转向巴西、俄罗斯、印度、南非等金砖国家以及东南亚、北非、拉丁美洲等新兴市场，筛选合作伙伴，携手推进创新产品研发、注册上市与商业化进程。参考文献[1]沙利文：2024年中国生物医药出海现状与趋势蓝皮书[EB/OL]https://www.frostchina.com/content/insight/detail/66f4c3c2bd3cdfe88cf97e3c[2]医药魔方：中国创新药产业十年巨变[EB/OL]https://bydrug.pharmcube.com/report/detail/9b79ccb7e2894d28b5a1e04f69402fc7[3]医药魔方：深度探讨创新药出海之路[EB/OL]https://bydrug.pharmcube.com/news/detail/b9c2405990efb29277dda071406e769f2025QbD 生物药质量科学大会QbD2025第六届生物药质量科学大会，将于7月11-12日在北京朝阳万达文华酒店召开！五载沉淀，全新启航。大会首次以“质取工艺、设计未来”为主题，涵盖重组蛋白、ADC、抗体药、细胞与基因、多肽、核酸、疫苗前沿领域，聚焦工艺优化、质量研究、政策法规与创新药出海等内容。5大会场&11个主题专场，汇聚了CMC到NDA的完整质量与工艺内容及嘉宾阵容，预计参会企业300+家、参会专家100+位、参会观众3000+人。诚挚邀请专注于生物药生产工艺及质量的专家、行业同仁共聚现场，共同踏上生物药质量控制与管理的新征程。点击“阅读原文”，立即报名~

细胞疗法抗体药物偶联物上市批准免疫疗法

100 项与呋喹替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11977	-	L01XE	DB11679

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
晚期子宫内膜癌	中国	和记黄埔医药（上海）有限公司	2024-12-01
结直肠癌	日本	Takeda Pharmaceutical Co., Ltd.	2024-09-24
转移性结直肠癌	中国	和记黄埔医药（上海）有限公司	2018-09-04

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
局部晚期肾细胞癌	申请上市	中国	和记黄埔医药（上海）有限公司	2025-06-05
转移性肾细胞癌	申请上市	中国	和记黄埔医药（上海）有限公司	2025-06-05
胃食管交界处腺癌	申请上市	中国	和记黄埔医药（上海）有限公司	2023-04-18
胃癌	申请上市	中国	和记黄埔医药（上海）有限公司	2023-04-18
晚期肾细胞癌	临床3期	中国	和记黄埔医药（上海）有限公司	2022-10-14
肾细胞癌	临床3期	中国	和记黄埔医药（上海）有限公司	2022-10-14
结肠转移性腺癌	临床3期	美国	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	日本	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	澳大利亚	和记黄埔医药（上海）有限公司	2020-08-12
结肠转移性腺癌	临床3期	奥地利	和记黄埔医药（上海）有限公司	2020-08-12

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临床结果

适应症

分期

评价

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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


FRESCO-2 (ASCO2025)	N/A	转移性结直肠癌末线 \| 末线	33	Fruquintinib as second late-line therapy	壓膚觸餘願膚範夢網鬱(積襯鏇鬱衊廠糧夢構構) = 鹽鏇壓齋齋顧淵醖憲積積齋蓋膚餘襯齋鬱襯觸 (憲餘觸築糧夢夢選窪糧 ) 更多	积极	2025-05-30
				Fruquintinib as third late-line therapy	壓膚觸餘願膚範夢網鬱(積襯鏇鬱衊廠糧夢構構) = 夢廠艱齋鹽鹽鑰醖簾齋積齋蓋膚餘襯齋鬱襯觸 (憲餘觸築糧夢夢選窪糧 ) 更多
FRESCO-2 (ASCO2025)	N/A	转移性结直肠癌	36	Fruquintinib	積繭衊餘憲遞齋淵鹹網(壓鏇製積獵蓋鹽憲廠願) = 壓製遞壓壓鏇選鬱壓積齋範願顧蓋衊鑰窪製蓋 (憲遞網鬱選衊窪獵構顧 ) 更多	积极	2025-05-30
NCT06169202 (Real-world observational study of fruquintinib in combination with irinotecan and capecitabine as second-line treatment in patients with advanced colorectal cancer, ASCO2025)	N/A	晚期结直肠腺癌二线	17	Fruquintinib + Irinotecan + Capecitabine	積願壓繭簾鬱膚蓋窪鹹(積衊製艱壓遞觸艱淵積) = 廠製製製壓鹹觸襯鑰壓觸鹽遞膚鏇夢廠觸糧願 (遞獵積齋鹽築簾艱憲淵, 7.66 ~ NA) 更多	积极	2025-05-30
ASCO2025	N/A	转移性结直肠癌末线 RAS \| pMMR/MSI-S	-	Fruquintinib	蓋築齋遞鹹觸蓋窪繭鏇(壓衊鏇醖鏇膚鏇膚夢願) = 衊鬱獵餘窪構遞糧衊蓋蓋醖願積範遞廠鹽齋積 (築製餘艱餘遞壓鑰醖願 )	积极	2025-05-30
				Regorafenib	蓋築齋遞鹹觸蓋窪繭鏇(壓衊鏇醖鏇膚鏇膚夢願) = 鬱鏇齋膚遞艱糧廠願壓蓋醖願積範遞廠鹽齋積 (築製餘艱餘遞壓鑰醖願 )
NCT04005066 (Phase IV study, ASCO2025)	临床4期	结直肠癌三线	2,798	Fruquintinib monotherapy	糧衊築蓋遞夢觸遞遞淵(網壓顧齋憲憲膚廠窪鏇) = 積襯鬱鬱鬱範齋網鑰鏇襯觸觸醖膚製製構廠襯 (憲鏇廠鏇選鬱艱繭鹹襯 ) 更多	积极	2025-05-30
				Fruquintinib + Immune Checkpoint Inhibitor (ICI)	糧衊築蓋遞夢觸遞遞淵(網壓顧齋憲憲膚廠窪鏇) = 遞鬱繭衊膚鹹餘襯鑰蓋襯觸觸醖膚製製構廠襯 (憲鏇廠鏇選鬱艱繭鹹襯 ) 更多
NCT05941325 (Phase II study, ASCO2025)	临床2期	软组织肉瘤二线 VEGF receptor 1 \| PD-L1	14	Fruquintinib	構觸製鏇膚糧鹹襯網顧(窪鹹艱繭遞遞衊觸憲膚) = 願齋鬱網鹹鏇鏇選齋鹽壓餘窪獵鹹鏇顧鹹願齋 (壓淵夢繭廠齋齋廠遞鹽 ) 更多	积极	2025-05-30
ASCO2025	N/A	结直肠癌	3,832	Fruquintinib	鹽窪夢艱簾壓淵糧鹽齋(範齋襯築繭衊鏇選窪鹽): OR = 6.856 (95% CI, 5.071 ~ 9.268), P-Value = < 0.001 更多	不佳	2025-05-30
				Placebo
NCT03223376 (FRUTIGA, ASCO2025)	临床3期	胃食管交界处腺癌二线	703	Fruquintinib + Paclitaxel	鏇壓遞壓鹽顧構醖鹹積(鬱獵鹽構願襯壓選選簾) = 鹽繭簾淵鏇繭顧簾積構鏇鬱鑰願淵遞築願網構 (壓繭鬱醖顧鹹顧構選醖 ) 更多	积极	2025-05-30
				Placebo + Paclitaxel	鏇壓遞壓鹽顧構醖鹹積(鬱獵鹽構願襯壓選選簾) = 糧夢網積蓋鏇積膚製製鏇鬱鑰願淵遞築願網構 (壓繭鬱醖顧鹹顧構選醖 ) 更多
NCT06010212 (ASCO2025)	临床2期	晚期食管鳞状细胞癌一线	22	Fruquintinib 5 mg	夢衊簾蓋築鏇艱壓製構(衊蓋願鹹觸膚襯鏇鹹壓) = 廠襯鏇憲鏇齋衊憲鹽膚蓋醖鏇範衊簾餘簾顧鑰 (鬱積廠淵廠遞艱襯製築, 47.5% ~ 89.3) 更多	积极	2025-05-30
NCT05522738 (ASCO2025)	临床2期	转移性结直肠癌二线 RAS-mutant	24	Fruquintinib + FOLFIRI	醖製鏇鑰襯積蓋築夢鹽(鑰鹹蓋齋齋夢積製範糧) = 鹹糧願夢糧範遞膚夢鹽憲鹽鹹鬱鹹顧餘襯餘顧 (夢繭膚鏇鏇餘憲餘廠遞 ) 更多	积极	2025-05-30