A Phase II Randomized Placebo-Controlled Study Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma

The aim of this study is to compare the efficacy and safety of YIV-906 plus standard-of-care sorafenib versus those of sorafenib alone as a first-line systemic treatment for patients with Hepatitis B (+) associated advanced hepatocellular carcinoma.
YIV-906 (PHY906, KD018) is an immune system modulator. Clinical and preclinical research suggests that YIV-906 could act to enhance the body's immune response to fight cancer and increase the anti-tumor activity of sorafenib and protect and repair the gastrointestinal tract by reducing inflammation and promoting tissue regeneration.
Inspired by a 1,800-year-old traditional medicine still in use today, YIV-906 is a botanical drug candidate, composed of an extract of four herbs and administered in oral capsule form.
The CALM (Combination of YIV-906 and Sorafenib to treat Advanced Liver cancer in a Multi-center study) trial is a multi-regional, randomized, placebo-controlled study.

开始日期2020-01-10

申办/合作机构

Yiviva, Inc.

NCT02178644

/ Completed临床1期IIT

Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer

This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.

开始日期2014-07-01

申办/合作机构

Yale University

NCT00730158

/ Completed临床2期IIT

A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer

The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.

开始日期2008-12-01

申办/合作机构

University of Pittsburgh

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100 项与 YIV-906 相关的临床结果

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100 项与 YIV-906 相关的转化医学

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100 项与 YIV-906 相关的专利（医药）

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项与 YIV-906 相关的文献（医药）

2025-09-01·JOURNAL OF CHROMATOGRAPHY A

Interpreting metabolic profiling of YIV906 in vivo: A Synergistic strategy combining LC–HRMS-based molecular networking and metabolomics thought integration

Article

作者: Lian Zhu ; Yung-Chi Cheng ; Ci Yang ; Aiping Tian ; Shwu-Huey Liu ; Liangyin Shu ; Kailin Li ; Wei Cai ; Qing Li

The components can be transformed into various metabolites that exert pharmacological effects under the action of gut microbiota and drug-metabolizing enzymes after administration of traditional Chinese medicine (TCM). However, the comprehensive characterization of herbal compounds in vivo is still an important challenge due to the interference of endogenous compounds. In this study, an integrated strategy was built to illustrate the metabolic profiling of YIV906 (PHY906), a standardized botanical cancer drug candidate originated from Huangqin Tang in vivo by combining multivariate statistical analysis and feature based molecular networking (FBMN) based on UHPLC-Q-Exactive orbitrap mass spectrometry. Firstly, a multivariate statistical analysis method was used to screen differential components on account of metabolomics approach. Meanwhile, the self-build database was built to preliminarily screen prototype components and then operated in the Compound Discoverer software to accelerate the discovery of metabolites based on Biotransformation module. Furthermore, a FBMN was constructed on the Global Natural Product Social (GNPS) platform to accurately annotate compound structures and infer unknown metabolites according to the differences of MS² spectra and m/z value with adjacent nodes. Finally, a total of 63 prototype components and 180 metabolites including flavonoid, organic acid, monoterpenoid, triterpenoid and alkaloid were successfully identified in rat plasma and tissues based on the established strategy, as well as revealed the tissue distribution characteristics of main components. In conclusion, this study demonstrated an effective and practical strategy that enables the in-depth metabolic profiling of complex biological samples.

2024-06-01·Journal of Gastrointestinal Oncology

A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer

Article

作者: Liu, Shwu-Huey ; Higgins, Susan A ; Lam, Wing ; Hochster, Howard ; Zaheer, Wajih ; Cheng, Yung-Chi ; Johung, Kimberly L ; Kortmansky, Jeremy ; Lacy, Jill ; Verma, Nipun ; Cecchini, Michael ; Stein, Stacey ; Reddy, Vikram

Background:

Pre-operative chemoradiation for rectal cancer is often associated with severe gastrointestinal (GI) toxicity which can interrupt, delay, and/or lead to termination of treatment. In this study, we evaluated whether the addition of YIV-906, a novel herbal medicine proven to reduce GI toxicity associated with chemotherapy could also reduce GI side effects during standard pre-operative capecitabine and pelvic radiation therapy (RT) in the neoadjuvant setting for the treatment of locally advanced rectal cancer.

Methods:

This single arm clinical study enrolled 24 patients between Dec 23, 2014-Sep 17, 2018 at Smilow Cancer Hospital, a comprehensive cancer center at Yale New Haven Hospital. All patients were age ≥18 years, Eastern Cooperative Oncology Group 0-1 and with histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the rectum. Median follow-up was 61.9 months. All patients received concurrent pelvic external beam RT (50.4 Gy in 28 fractions), YIV-906 (taken orally 800 mg twice daily on days 1-4 of RT each week), and oral capecitabine delivered in a neo-adjuvant fashion, followed by definitive surgery. Toxicity was assessed weekly during radiation and until acute symptoms resolved and then at 28 days, 4 months, 7 months and 10 months. Toxicities were graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Results:

At the time of surgery, 4 patients (16.7%) had a complete or near-complete response. At a median follow-up of 61.9 months, the mean overall survival (OS) of our patient cohort was 74.9 months [95% confidence interval (CI): 67.3-82.5]. The estimated 5-year OS was 82.0%. We observed 0% acute grade 4 toxicities, and only two cases of acute grade 3 diarrhea (8.3%).

Conclusions:

The addition of YIV-906 to capecitabine based chemoradiation for locally advanced rectal cancer led to reduced rates of GI toxicity compared to historical controls, in particular grade 3 or greater diarrhea. These findings suggest YIV-906 should be evaluated in a randomized clinical trial to further assess potential reductions in the toxicity profile of chemoradiation for GI cancers.

2024-01-01·Integrative cancer therapies

Efficiency of Protective Interventions on Irinotecan-Induced Diarrhea: A Systematic Review and Meta-Analysis

Review

作者: He, Bing ; Zhang, Wei ; He, Yanxi ; Qi, Xiaoyi ; Xiong, Xia ; Liang, Sicheng ; Wang, Xuan ; Wang, Yu ; Wu, Lili ; Zhao, Wenjing ; Deng, Mingming

Background::

Irinotecan is widely used in the treatment of various solid tumors, but the adverse effects from it, especially diarrhea, limit its use. Several clinical trials of prophylactic treatment of irinotecan-induced diarrhea (IID) have been ongoing, and some of the data are controversial. This encouraged us to conduct a meta-analysis of the effects of interventions on preventing IID.

Method::

This systematic review was conducted based on the PRISMA statement. We performed literature searches from PubMed, Web of Science, Embase, and Cochrane Library. The number registered in PROSPERO is CRD42022368633. After searching 1034 articles in the database and references, 8 studies were included in this meta-analysis.

Result::

The RR of high-grade diarrhea and all-grade diarrhea were 0.31 ( I2 = 51%, 95% CI: 0.14-0.69; P = .004) and .76 ( I2 = 65%, 95% CI: 0.62-0.93; P < .008) respectively, thus the use of intervention measures for preventing IID is effective, and the risk reduction of high-grade diarrhea was more significant. Subgroup analysis revealed that the monotherapy group (RR: 0.48, 95% CI: 0.21-1.13, I2 = 0%) and combination therapy group (RR: 0.14, 95% CI: 0.06-0.32, I2 = 0%) in the risk of high-grade diarrhea had no significant heterogeneity within the groups, and traditional herbal medicines (Kampo medicine Hangeshashin-to, PHY906 and hot ironing with Moxa Salt Packet on Tianshu and Shangjuxu) were effective preventive measures (RR:0.20, 95% CI: 0.07-0.60, I2 = 0%). The Jadad scores for traditional herbal medicines studies were 3, and the follow-up duration was only 2 to 6 weeks.

Conclusion::

This systematic review and meta-analysis suggest that preventive treatments significantly reduced the risk of high-grade and all-grade diarrhea, confirming the efficacy in the incidence and severity of IID, among which traditional herbal medicines (baicalin-containing) provided a protective effect in reducing the severity of IID. However, the traditional herbal medicines studies were of low quality. Combined irinotecan therapy can obtain better preventive effects than monotherapy of IID. These would be helpful for the prevention of IID in clinical practice.

项与 YIV-906 相关的新闻（医药）

2026-03-17

·药研逻辑

3·15点名外泌体！从干细胞到脑机接口，盘点被严重透支的医学前沿

昨晚的央视315晚会，将医美与健康领域滥用外泌体等概念的乱象公之于众。套证生产、违规添加、甚至将缺乏有效监管的生物制剂包装成所谓包治百病的神药注入消费者体内，引发了严重的医疗安全隐患。令人痛心的是，外泌体并非孤例。在当前的健康与医疗市场中，科研人员还在实验室死磕机制，部分商业机构却已经拿着半成品甚至假概念变现的荒诞剧正在轮番上演。 315晚会曝光外泌体乱象（来源：央视315晚会曝光外泌体违规乱象. 2024. 央视新闻）今天，我们就以药学研发的底层逻辑与循证医学视角，来盘点那些被过度包装、严重透支的医学重灾区。 🛑 重灾区一，再生与修复的狂欢，涵盖外泌体、干细胞与脐带血。这往往是抗衰与健康焦虑领域的重灾区，部分机构最喜欢借用细胞再生与逆转衰老的噱头。科研真实现状与学术证据显示，外泌体作为天然的纳米级递送载体，被业界寄予厚望，视为继抗体偶联药物与脂质纳米颗粒之后的下一代靶向递送平台。但真正的药研人深知其成药的艰难。近年来，单细胞测序和空间转录组学研究揭示了外泌体极端的异质性。目前全球进入一期或二期早期临床的外泌体管线，绝大多数都是在死磕生存率极低的重症。外泌体蛋白在癌症生物学的作用（来源：The updated role of exosomal proteins in the diagnosis, prognosis, and treatment of cancer. 2022. Experimental and Molecular Medicine）在肿瘤治疗领域。顶尖肿瘤专科医院 MD Anderson 癌症中心正在推进一项一期临床，利用装载针对 KRAS 突变 siRNA 的外泌体来死磕癌王晚期胰腺癌。此外，外泌体先驱企业 Codiak BioSciences 曾将装载免疫激动剂的工程化外泌体推入临床，试图将其精准递送至实体瘤微环境中，从内部瓦解肿瘤屏障。评估载有KrasG12D siRNA的间充质干细胞源性外泌体治疗转移性胰腺癌的I期研究（来源：Phase I Study of iExosomes NCT03608631. 2022. ClinicalTrials.gov）针对晚期转移性实体瘤的首次人体一二期临床研究（来源：Phase I/II Study of exoSTING NCT04592484. 2020. ClinicalTrials.gov）重症呼吸衰竭。前沿生技公司 Direct Biologics 研发的骨髓间充质干细胞衍生外泌体产品 ExoFlo，目前正在开展针对中重度急性呼吸窘迫综合征（ARDS）的临床试验，用来挽救重症 ICU 里的生命。使用细胞外囊泡外泌体治疗中重度急性呼吸窘迫综合征的III期临床试验（来源：Phase III Study of ExoFlo NCT05354141. 2022. ClinicalTrials.gov）然而，市场却充斥着超适应症的乱象。除了外泌体，干细胞被滥用也是重灾区。以间充质干细胞为代表的干细胞面临着提取纯化难、异体排斥等严峻的药学壁垒，获批适应症极其严格。面对连化学、制造和控制壁垒都尚未完全攻克的难题，部分非正规机构却将成分不明的制剂标榜为医用级外泌体或高价干细胞。这些跨越严苛临床试验、直接在人体进行的所谓保健干预，不仅面临极大的免疫排斥风险，更可能带来细胞异常增殖的安全隐患。干细胞乱象早有实锤。顶级医学期刊新英格兰医学杂志曾报道多起恶性事件，患者因在私营诊所接受未经 FDA 批准的干细胞注射，最终导致其双目失明或脊髓长出异常畸胎瘤肿瘤等严重后果。干细胞注射恶性事件（来源：Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD. 2017. New England Journal of Medicine）此外，针对新手父母的自费存储脐带血商业宣传也存在严重夸大。自体脐带血用于自身治疗遗传病或白血病的概率极低，且单份血量往往不足以支撑成年后的使用。美国儿科学会发布的官方指南明确指出，不推荐将脐带血储存在私营血库以备将来自身或家庭成员使用，因为自身干细胞通常携带着与发病机制相同的基因缺陷，真实使用概率极低，大约在四百分之一至二十万分之一之间。 AAP不推荐将脐带血储存在私营血库以备将来自身或家庭成员使用（来源：Policy Statement Cord Blood Banking for Potential Future Transplantation. 2017. American Academy of Pediatrics）🛑 重灾区二：神化的传统医学，宣称包治百病的秘方。中医药在肿瘤治疗中的真实作用需要被客观认知，我们既不能全盘否定，也不应将其神化为替代常规疗法的神丹妙药。科研真实现状与边界在于，合规中医药在现代肿瘤学中的定位主要是辅助干预。高质量的临床证据表明，规范的中医药在改善实体瘤患者生存质量、重塑肿瘤免疫微环境调节特定抑制性细胞活性，以及逆转或减轻靶向药和化疗带来的骨髓抑制与心血管毒副作用方面，具有极高的辅助价值。比如在缓解药物副作用方面，中医药非药物疗法取得了教科书级别的突破。在针对早期乳腺癌患者的临床研究中，真针灸组在 6 周末和 12 周末的疼痛评分下降幅度具有极高的统计学意义，而且在停针后效果能维持极长时间。这是中医药疗法首次以如此严谨的 III 期随机对照临床试验设计登上医学顶刊，用详实的数据证明了其确切的临床获益。真针灸组与对照组的疼痛评分变化对比曲线（来源：Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer A Randomized Clinical Trial. 2018. JAMA）除了非药物疗法，现代化的中药复方在逆转靶向药毒副作用方面同样表现优异。以黄芩汤的现代衍生药 YIV-906 为例，它显著降低了索拉非尼引发的严重非血液学毒性，包括腹泻、恶心、呕吐和手足综合征。更令人瞩目的是，实验组的中位总生存期达到 14.3 个月，对比对照组的 8.0 个月，患者的死亡风险显著下降。 YIV-906联合索拉非尼治疗晚期肝癌的生存曲线与毒性对比（来源：International phase II randomized placebo-controlled study investigating the combination of YIV-906 plus sorafenib SORA in HBV positive patients with advanced hepatocellular carcinoma. 2023. Journal of Clinical Oncology）然而与这些扎实的前沿探索形成鲜明对比的是，部分缺乏监管的灰色地带中，包治百病的宣传屡见不鲜。部分不良商家利用晚期患者的求生欲，兜售所谓能彻底消除肿瘤的秘方，甚至暗中违规添例如糖皮质激素或廉价化疗药等大剂量西药成分。这种违规掺杂物不仅无法有效控瘤，还会因剂量失控导致不可逆的肝肾功能衰竭，严重贻误正规治疗时机。国家药监局每年都会通报多起假药案件，不法分子常在号称祖传中药的胶囊中非法添加双氯芬酸钠、醋酸泼尼松甚至格列本脲等处方化药，以制造一吃就见效的假象，最终导致患者产生严重的肝肾毒性和消化道大出血。国家药监局公布第四批药品安全专项整治典型案例XZXK-2023-10013（来源：第四批药品安全专项整治典型案例. 2023. 国家药品监督管理局） 🛑 重灾区三：免疫神话与泛化细胞疗法。靶向肿瘤微环境中的免疫细胞是当今前沿的抗癌策略。将特定免疫细胞在体外进行严格的基因工程改造与扩增，是目前攻克难治性血液肿瘤的重要手段。肿瘤微环境交互（来源：Metabolic modulation of immune checkpoints and novel therapeutic strategies in cancer. 2022. Seminars in Cancer Biology）严肃的医学探索，却在部分商业营销中被包装成了自体NK细胞回输防癌抗衰与输入年轻血液永葆青春。事实上，异体共生模型严格停留在模式动物实验阶段。脱离了极其严格的供体筛查和无菌制备环境，将未经严格质控的体外扩增细胞直接回输体内，不仅缺乏大规模临床数据支撑，更面临极高的感染与免疫风暴风险。所谓的年轻血液抗衰的说法早已被官方辟谣。美国食品药品监督管理局曾发布极其严厉的警告，明确指出没有证据表明输入年轻捐献者的血浆可以治疗衰老、痴呆或记忆力减退。官方严厉打击提供此类高价换血服务的私营诊所，指出其存在败血症和严重过敏等致命风险。输注血浆缺乏临床试验证据支持且可能带来感染与心血管系统等风险（来源：Important Information about Young Donor Plasma Infusions for Profit. 2019. U.S. Food and Drug Administration）自魏则西事件后，国家卫健委明确要求停止公立医院未经批准的细胞免疫疗法商业化收费。细胞的体外扩增如果缺乏极高标准的无菌质控，极其容易导致致命的细菌感染与败血症。某公立医院擅自使用细胞治疗肿瘤被叫停，该院多个科室为癌症患者提供未获批的NKT免疫细胞治疗服务（来源：某公立医院擅自使用细胞治疗肿瘤被叫停. 2024. 第一财经新闻） 🛑 重灾区四：微生态的万金油营销与违规移植。关于肠道微生态，粪菌移植作为一种严肃的医疗手段，目前在临床上仅被国内外权威指南推荐用于治疗常规抗生素无效的复发性艰难梭菌感染等极少数明确适应症。 2024 BSG与HIS联合指南推荐粪菌移植治疗复发性或难治性艰难梭菌感染或其他潜在适应证（The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides difficile infection and other potential indications. 2024. Journal of Hospital Infection）如今微生态概念被严重泛化，市场上诸多口服产品强行添加益生菌字眼以获取溢价。而药代动力学的常识是，未经特殊包埋技术的普通产品，经过胃酸和胆盐洗礼后，其肠道定植存活率极低。将极其复杂的肠道微生态网络，简单粗暴地化为应对各类健康焦虑的万金油，本质上是对科学概念的过度营销。私营粪菌移植同样存在致命风险，FDA 曾多次发布严重安全警告，指出因使用未经严格筛查的粪菌移植供体，导致受试者感染多重耐药菌甚至引发致命败血症死亡的案例，严禁机构在缺乏监管的情况下滥用粪菌移植。粪便移植后出现了由肠致病性大肠杆菌 EPEC 两例或产志贺毒素大肠杆菌 STEC 四例（来源：Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events. 2022. U.S. Food and Drug Administration）🛑 重灾区五：神经与认知的狂想，概念化的脑机接口。随着前沿科技公司的突破，真正的脑机接口目前主要聚焦于极端重症的神经功能重建。例如帮助渐冻症或高位截瘫患者通过意念控制光标，从而恢复交流能力。此类技术面临极高的侵入性手术风险，且电极材料的长期生物相容性仍是世界级难题。植入物直径与美国25美分硬币的直径大致相同，通过分布在许多细而柔韧的细线上的1000多个电极来精确记录深层神经活动（来源：Brain-Computer Interfaces. 2024. Neuralink官网）然而极其严肃的神经外科学，却在部分消费市场被异化为脑波赋能的噱头。宣称佩戴简易头环就能提升专注力与全脑开发的产品层出不穷。实际上，人类头皮表面的脑电信号极其微弱且极易受干扰，仅仅依靠简单的体表传感器就宣称能提升智力，是完全缺乏严谨的神经科学依据的。小学生头环监控走神设备（来源：小学生戴头环监控走神被指紧箍咒. 2019. 新华网）💡 敬畏生命，究竟什么才是真正有临床价值的药研逻辑？真正的药研能让传统毒药脱胎换骨。中国科学家用现代分子生物学阐明了三氧化二砷降解 PML-RARα 融合蛋白的机制，用严谨的临床试验证明疗效，硬生生将砒霜变成了获 FDA 批准、拯救无数急性早幼粒细胞白血病患者的现代靶向药。砒霜靶向降解机理（来源：Acute promyelocytic leukemia, arsenic, and PML bodies. 2012. Journal of Cell Biology）港大口服砒霜已获得美国食品及药品管理局FDA及欧洲药品管理局EMA（来源：港大口服砒霜已獲得美國食品及藥物管理局FDA及歐洲藥品管理局EMA. 2018. 香港大学李嘉诚医学院官网）真正的研发要在失败泥潭中重塑肿瘤微环境。很多人曾以为免疫疗法是万能神药，但真实的临床现状是，由于复杂的微环境屏障导致免疫抑制，大量免疫临床试验折戟沉沙。如今的前沿探索，是利用单细胞测序和空间转录组学剥丝抽茧，试图精准打破这些屏障，或是利用抗体偶联药物精准的旁观者效应，强行在耐药的实体瘤中撕开突破口。 ADC药物旁观者效应机制（来源：Antibody drug conjugates and bystander killing is antigen-dependent internalisation required. 2017. British Journal of Cancer）严肃的临床研究必须直面真实的生存获益与治疗毒性。药研不仅是为了把肿瘤杀小，更是为了让患者活得久。研究人员绝不会回避创新药带来的代价，他们正在极力攻克免疫疗法和抗体偶联药物带来的严重心血管毒性与间质性肺炎等致命副作用，力求在抗癌与保护器官功能之间找到真正的平衡。终极拷问：既然缺乏充分验证，为何还有人觉得这些疗法有效？这背后离不开临床试验中著名的安慰剂效应。当患者花费高昂代价，怀揣极大期望接受了某些未经严格验证的前沿干预后，情绪的改善确实能在短期内产生强烈的心理暗示，从而主观上感觉症状减轻与精力充沛。但是心理暗示无法逆转真实的病理改变。将这种主观上的好转假象，等同于肿瘤缩小与器官功能实质性改善等客观生理指标的扭转，是极具误导性的。更令人担忧的是，盲目追求未经充分验证的疗法，往往可能导致患者错失正规手术或靶向免疫干预的最佳临床窗口期。做生物医药研发与健康科普，需要对得起医学的严谨。我们需要的是基于循证医学的真实数据，而不是虚构的概念。只有让前沿技术回归严谨的药研逻辑，才能迎来真正安全、合规的临床转化。 👆 探索更多转化医学底层逻辑，欢迎关注。我们继续前进！如果你对单细胞多组学如何赋能新药研发感兴趣，推荐继续阅读：拒绝生信内卷！牛津团队仅凭4个样本砸百万做空转，活体亚细胞空间组学重塑研发范式从“强拆”到“重编程”：张泽民院士团队顶刊揭秘，寻找控制细胞命运的终极开关从“盲盒”到“明牌”：不看单细胞和空间组学，新药立项还有戏吗？从 SHP2 悖论看实体瘤靶向治疗的“生态学转向” 别让昂贵的单细胞测序沦为“发文机器”：一线实验室真正关心的临床转化痛点是什么？参考文献 References 1. Dai, J. et al. 2022. The updated role of exosomal proteins in the diagnosis, prognosis, and treatment of cancer. Experimental and Molecular Medicine. 2. ClinicalTrials.gov. 2022. Phase I Study of iExosomes NCT03608631. National Institutes of Health. 3. ClinicalTrials.gov. 2020. Phase I/II Study of exoSTING NCT04592484. National Institutes of Health. 4. ClinicalTrials.gov. 2022. Phase III Study of ExoFlo NCT05354141. National Institutes of Health. 5. Kuriyan, A. E. et al. 2017. Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD. New England Journal of Medicine. 6. American Academy of Pediatrics. 2017. Policy Statement Cord Blood Banking for Potential Future Transplantation. Pediatrics. 7. Hershman, D. L. et al. 2018. Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer. JAMA. 8. Harding, J. J. et al. 2023. International phase II randomized placebo-controlled study investigating the combination of YIV-906 plus sorafenib SORA in HBV positive patients. Journal of Clinical Oncology. 9. 国家药品监督管理局. 2023. 第四批药品安全专项整治典型案例 XZXK-2023-10013. 国家药品监督管理局官网. 10. Li, X. et al. 2022. Metabolic modulation of immune checkpoints and novel therapeutic strategies in cancer. Seminars in Cancer Biology. 11. U.S. Food and Drug Administration. 2019. Important Information about Young Donor Plasma Infusions for Profit. FDA Safety Communication. 12. 第一财经新闻. 2024. 某公立医院擅自使用细胞治疗肿瘤被叫停. 网易新闻. 13. Mullish, B. H. et al. 2024. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides difficile infection and other potential indications. Journal of Hospital Infection. 14 U.S. Food and Drug Administration. 2022. Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events. FDA Safety Alert. 15. Neuralink. 2024. Brain-Computer Interfaces. Neuralink官网. 16. 新华网. 2019. 小学生戴头环监控走神被指紧箍咒. 新华社. 17. Lallemand-Breitenbach, V. et al. 2012. Acute promyelocytic leukemia, arsenic, and PML bodies. Journal of Cell Biology. 18. 香港大学李嘉诚医学院. 2018. 港大口服砒霜已獲得美國食品及藥物管理局FDA及歐洲藥品管理局EMA. 港大医学院官网新闻. 19. Staudt, N. D. et al. 2017. Antibody drug conjugates and bystander killing is antigen-dependent internalisation required. British Journal of Cancer. 免责声明，本文内容仅代表作者作为医药研发领域从业者的学术观点与行业观察，旨在进行科学普及与机制探讨。本文不构成任何具体的医疗诊断或治疗建议。患者如有相关疾病需求，请务必前往正规医疗机构，遵从专业医师和指南的指导意见。

siRNA临床1期临床2期

2025-07-10

·GlobeNewswire-Health Care

Yiviva Presents Phase 2b Results for YIV-906 in Combination with Sorafenib in Advanced Hepatocellular Carcinoma at ASCO and ESMO GI 2025

July 07, 2025 -- Yiviva, a clinical-stage biotechnology company pioneering systems biology-driven therapeutics, announced data from its multi-regional, randomized, double-blind, placebo-controlled Phase 2b study of sorafenib (SORA) with or without YIV-906 in advanced hepatocellular carcinoma (HCC) patients with chronic hepatitis B (HBV+). Results were highlighted in an American Society of Clinical Oncology (ASCO) Annual Meeting (May 30-June 3) abstract and presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Annual Congress 2025 (July 2-July 5) poster. Presented by Dr. Ghassan Abou-Alfa MD, JD, MBA, PhD(hc), medical oncologist at Memorial Sloan Kettering Cancer Center, the study demonstrated improvements in both efficacy and tolerability for patients treated with YIV-906 plus sorafenib versus sorafenib monotherapy. 4.1 months vs. 3.5 months in the intention-to-treat (ITT) analysis Median Overall Survival (mOS): 14.3 months vs 7.5 months Median Time to Tumor Progression (mTTP): 5.59 months vs. 2.33 months Safety and Tolerability: Patients on the YIV-906 arm patients demonstrated greater duration of treatment exposure and continuation and were able to remain on treatment longer More than 250 GI (liver, pancreatic, colorectal, rectal) cancer patients treated in YIV-906 clinical studies have demonstrated proof-of-concept efficacy and safety. YIV-906 is a novel multi-targeted modality developed using a systems biology approach. YIV-906 increases the therapeutic index by acting as an immunomodulator in the tumor microenvironment (TME) and potentiating antitumor activity YIV-906 reprograms and primes the TME (STING, IFNg, IFNb, P-IRF3) and enhances innate immunity by polarizing and increasing M1 like macrophage infiltration and enhancing apoptosis. YIV-906 enhances adaptive immunity by promoting T-cell activation (promoting NFAT, inhibiting SHP1 and SHP2), modulating immune checkpoints (PD1/PDL1), reducing immune tolerance (by suppressing IDO), YIV-906 increases safety and reduces non-hematological toxicities by cytoprotecting the gastrointestinal tract by reducing GI inflammation (NF-kB, COX2, iNOS, IL-6), promoting damaged tissue repair (Wnt pathway), and reducing pain (NK1). “These results demonstrate the obligation to further study YIV-906’s potential to benefit hepatocellular carcinoma patients with hepatitis B who have limited treatment options,” said co-principal investigator Prof. Dr. Ghassan Abou-Alfa. “YIV-906 could broaden the therapeutic index and improve efficacy, safety and tolerability, and merits further clinical exploration with other studies and standards-of-care as a potential new treatment modality and paradigm.” The Phase 2b study (NCT04000737) randomized (2:1) patients (n=62) with treatment-naïve, advanced HBV-positive HCC, Child-Pugh A, BCLC Stage B or C, and ECOG ≤1 to either the YIV-906 + sorafenib arm or the placebo + sorafenib arm. Patients were enrolled in multiple regions (United States, Mainland China, Hong Kong, Taiwan) and the study was conducted from January 2020 to November 2024. The primary endpoint was progression free survival (PFS); secondary endpoints included overall survival (OS), time to progression (TTP), objective response rate (ORR), diseases control rate (DCR), safety and tolerability, and quality of life (QoL). More detailed information is available through 2025 ASCO Abstract # e16244 and ESMO GI Poster #P172. The study was sponsored by Yiviva with grant support from the Henry Bronson Endowment of Yale University, National Foundation for Cancer Research, Asian Fund for Cancer Research, and China 13-5 National Major Scientific and Technological Special Project for Significant New Drug Development. YIV-906 (formerly known as PHY906 or KD018) is a patented, orally administered investigational drug that acts as a pan-adjuvant improving the efficacy and safety for a broad spectrum of cancer drugs and regimens (including chemotherapies, immunotherapies, radiation, and cell therapies). YIV-906 has been studied in nine clinical trials in solid tumors (hepatocellular carcinoma, pancreatic cancer, colorectal cancer, and rectal cancer) with data demonstrating the potential for YIV-906 to improve overall survival and/or progression-free survival and reduce non-hematological toxicities (including diarrhea, nausea, vomiting, fatigue, and hand-foot syndrome). YIV-906 was inspired by an 1800-year-old traditional medicine and is being developed under the United States Food and Drug Administration’s (FDA) botanical drug regulatory pathway. The FDA has granted YIV-906 two Orphan Drug Designations (ODD) for the treatment of hepatocellular carcinoma and pancreatic cancers. Yiviva is committed to developing innovative medicines using a multi-targeted systems biology approach to improve survival and quality of life for patients with cancer and other serious diseases. The platform biotechnology company was launched with Yale University and Henry Bronson Professor of Pharmacology and Medicine Yung-Chi Cheng as co-founders, with teams in the United States and Asia. The content above comes from the network. if any infringement, please contact us to modify.

临床结果孤儿药ASCO会议免疫疗法

2024-08-13

·drugs

Chinese Botanical Medicine Eases a Cancer Treatment Side Effect

TUESDAY, Aug. 12, 2024 -- An experimental drug based on ancient Chinese herbal medicine can help ease the toxic side effects of chemotherapy and radiation therapy in cancer patients, the results of a small new trial results suggest. A small group of 24 patients experienced fewer GI side effects from their treatment for rectal cancer after they took YIV-906, researchers reported recently in the Journal of Gastrointestinal Oncology . YIV-906 is based on an 1,800-year-old treatment for stomach ailments that combined licorice, dates, peonies and skullcap, researchers said. “This study is the first demonstration of YIV-906’s effectiveness in reducing GI toxicity caused by chemotherapy and radiation, showing the medicine’s potential of improving the patient’s quality of life while increasing treatment effectiveness,” said co-researcher Yung-Chi Cheng , a professor of pharmacology at Yale School of Medicine who helped develop the drug. For the four-year, phase 2 study, the patients were given capsules of YIV-906 along with chemo and radiation prior to surgery. At the time of surgery, about 17% of patients had a complete or near-complete response to their cancer treatment, while the overall survival rate at five years was 82%, results show. Only two cases of severe diarrhea were reported among the patients. YIV-906 is meant to ease side effects like diarrhea, fatigue and nausea. “We didn’t have any serious toxicity associated with the drug and patients found taking the drug in pill form very easy and tolerable,” senior researcher Dr. Susan Higgins , a professor of therapeutic radiology and of obstetrics, gynecology, and reproductive sciences at Yale. The results warrant further testing of YIV-906 in more patients with other types of cancer, such as pelvic cancer, researchers said in a Yale new release. People taking YIV-906 might be able to withstand harsher doses of both chemo and radiation therapy, making their cancer treatment more effective, the researchers added. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果放射疗法临床2期

100 项与 YIV-906 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床2期	美国	Yale University	2022-06-15
晚期肝细胞癌	临床2期	美国	Yiviva, Inc.	2020-01-10
晚期肝细胞癌	临床2期	中国	Yiviva, Inc.	2020-01-10
晚期肝细胞癌	临床2期	中国香港	Yiviva, Inc.	2020-01-10
晚期肝细胞癌	临床2期	中国台湾	Yiviva, Inc.	2020-01-10
转移性结直肠癌	临床2期	美国	Kadmon Corp. LLC	2008-12-01
转移性胰腺腺癌	临床2期	美国	PhytoCeutica, Inc.	2006-12-01
转移性胰腺腺癌	临床2期	美国	Roche Pharma AG	2006-12-01
不可切除的肝细胞癌	临床2期	美国	PhytoCeutica, Inc.	2003-10-01
不可切除的肝细胞癌	临床2期	中国台湾	PhytoCeutica, Inc.	2003-10-01

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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


NCT04000737 (ESMO_GI2025) 人工标引	临床2期	肝细胞癌辅助 HBV(+)	107	Sorafenib + YIV-906	膚簾鏇繭範遞選鹽獵築(淵夢範願膚選艱餘鏇築) = 鹹觸繭簾範顧壓蓋製鹽遞鬱艱廠蓋築範鹽獵齋 (觸選壓壓襯製廠積衊膚 ) 更多	积极	2025-07-03
				Placebo+Sorafenib	膚簾鏇繭範遞選鹽獵築(淵夢範願膚選艱餘鏇築) = 蓋糧艱醖鹽膚簾齋夢構遞鬱艱廠蓋築範鹽獵齋 (觸選壓壓襯製廠積衊膚 ) 更多
NCT04000737 (International phase II randomized placebo-controlled study, ASCO2025)	临床2期	晚期肝细胞癌一线 HBV (+)	107	YIV-906 + Sorafenib	簾鏇觸窪範選範築鏇醖(鹹壓餘窪築醖餘獵膚廠) = improvement was also observed by the investigator 夢觸範餘齋夢齋獵蓋糧 (選憲構觸窪膚願觸顧糧 ) 更多	积极	2025-05-30
				Placebo
NCT00730158 (CTgov)	临床2期	转移性结直肠癌	33	Irinotecan+KD018 (Arm A - Irinotecan + KD018)	艱鹽繭壓鏇遞鹹選獵簾 = 鬱構簾醖鑰顧鑰構襯醖積鹽願窪艱築糧築築範 (夢繭願壓築積淵艱糧憲, 壓窪顧廠遞獵窪鹹鑰膚 ~ 窪壓網簾製顧壓齋選淵) 更多	-	2019-05-22
				Placebo+Irinotecan (Arm B - Irinotecan + Placebo)	艱鹽繭壓鏇遞鹹選獵簾 = 壓獵觸廠製鑰鹽繭構蓋積鹽願窪艱築糧築築範 (夢繭願壓築積淵艱糧憲, 顧網構鏇膚壓鬱衊簾鏇 ~ 觸觸淵積齋襯觸窪構顧) 更多
NCT00411762 (CTgov)	临床1/2期	转移性胰腺腺癌 \| 胰腺癌	25	Capecitabine+PHY906	簾憲顧簾簾鹹壓醖齋艱(觸蓋範築顧艱築鏇積衊) = 觸獵製獵獵鹹壓繭繭願鹹簾衊鹽製膚艱鹹獵鑰 (窪鏇願膚蓋醖淵醖艱壓, 鏇餘繭獵遞構鏇製觸壓 ~ 構蓋糧鏇醖夢醖選選艱) 更多	-	2015-03-27
Pubmed \| Cancer Chemother Pharmacol	临床2期	胰腺癌二线	25	Capecitabine + PHY906	積壓積襯遞願艱鏇壓簾(襯顧顧憲願鹽衊蓋選齋) = 鑰醖廠鏇糧鬱衊構繭鏇憲繭構網願積繭衊鹽鹽 (壓築遞選鑰膚淵艱繭夢 ) 更多	-	2014-02-01
ASCO2010	临床2期	胰腺癌	25	PHY906 plus capecitabine (CAP)	鑰衊鹽簾顧製淵夢糧築(簾壓襯夢艱壓鹽蓋齋製) = 獵構築網選鹹壓積憲憲糧鏇鏇窪遞齋鹹憲鏇淵 (鹽艱糧積鹽獵簾鹽窪鹽 ) 更多	-	2010-05-20
NCT04000737 (Pubmed)	临床1/2期	晚期肝细胞癌	-	PHY906	窪壓齋網鏇網網範鏇積(衊蓋醖醖廠築窪顧鬱廠) = 齋鹹廠艱淵齋顧簾醖遞繭夢襯願範遞顧網鏇選 (築鬱淵壓壓築觸築鏇衊 ) 更多	-	2009-10-01
ASCO2009	N/A	胃肠道肿瘤	44	PHY906	構積艱顧夢淵餘鏇壓網(醖簾餘憲願窪鬱壓壓獵) = 憲壓憲築網餘淵鏇膚網廠淵構顧鹽觸願簾廠夢 (鹹鑰顧鹽顧壓憲淵繭淵 )	-	2009-05-20
				CAP alone	構積艱顧夢淵餘鏇壓網(醖簾餘憲願窪鬱壓壓獵) = 膚齋觸築鏇觸襯鏇獵膚廠淵構顧鹽觸願簾廠夢 (鹹鑰顧鹽顧壓憲淵繭淵 )
ASCO2007	临床1/2期	肝细胞癌	18	PHY906 + Capecitabine 1000 mg/m2 BID	網襯鑰鏇繭壓獵膚窪積(餘廠顧襯築衊製淵衊廠) = 壓衊艱積壓顧選範醖淵鏇製顧淵淵願築簾選艱 (網簾窪鏇淵築製襯壓積 ) 更多	-	2007-06-20
				PHY906 + Capecitabine 750 mg/m2 BID	網襯鑰鏇繭壓獵膚窪積(餘廠顧襯築衊製淵衊廠) = 遞鹽淵廠簾糧鑰蓋膚遞鏇製顧淵淵願築簾選艱 (網簾窪鏇淵築製襯壓積 ) 更多