Pexastimogene devacirepvec

The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs. A few leaders, such as Candel Therapeutics, Binhui Biopharmaceutical, Oncolytics Biotech, EpicentRx, Hangzhou Converd, and others, anchor the mid and late-stage pipeline. LAS VEGAS, Feb. 4, 2026 /PRNewswire/ -- DelveInsight's Oncolytic Virus Competitive Landscape 2026 report provides comprehensive global coverage of pipeline oncolytic virus therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and the competitive landscape, highlighting the strategies of major pharmaceutical companies to advance their pipelines and capitalize on future growth opportunities. In addition, it provides critical insights into clinical trial benchmarking, partnering and licensing, and regulatory pathways with the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies in the oncolytic virus domain. Oncolytic Virus Clinical Trial Analysis Summary DelveInsight's oncolytic virus pipeline report highlights a robust landscape, with 100+ active players developing 110+ oncolytic virus drugs. Key oncolytic virus companies such as Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others are evaluating new oncolytic virus drugs to improve the treatment landscape. Promising pipeline oncolytic virus therapies, such as Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others, are in different phases of oncolytic virus clinical trials. Request a sample and discover the recent advances in oncolytic virus drugs @ Key Factors Driving the Oncolytic Virus Therapy Market Growing Cancer Incidence: The global rise in cancer prevalence, especially in hard-to-treat solid tumors, has intensified demand for novel, effective treatment modalities. Conventional therapies such as chemotherapy and radiation often have significant side effects and limited long-term efficacy, motivating the adoption of immunotherapeutic alternatives like oncolytic virus therapies. Increasing Understanding of Cancer Biology: Growing knowledge of cancer biology has enabled the development of oncolytic virus therapies that selectively target and destroy cancer cells while sparing healthy cells. Advancements in Viral Engineering: These advances are enabling more precise, targeted oncolytic virus therapies, significantly expanding the global oncolytic virus therapy market. Rising Adoption of Personalized Medicine: Oncolytic virus therapies align closely with personalized treatment approaches by enabling tailored viral constructs and immunomodulatory payloads based on tumor genomics. What is Oncolytic Virus Therapy? Oncolytic virus therapy is an innovative form of cancer treatment that uses genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells. These viruses replicate inside tumor cells, causing them to burst while leaving healthy cells largely unharmed. As the cancer cells break apart, they release tumor antigens that help activate the body's immune system, enhancing its ability to recognize and attack remaining cancer cells. This dual action, direct tumor destruction and immune stimulation, makes oncolytic virus therapy a promising approach in modern oncology, often used alongside other treatments such as immunotherapy or chemotherapy. Applications of Oncolytic Virus Therapy Oncolytic virus (OV) cancer therapies can be used for both diagnosis and treatment of cancer. OVs can function as cancer vaccines by boosting tumor-specific T-cell responses. Oncolytic viruses can be engineered with immunostimulatory molecules to enhance immune activation. OVs show strong synergy when combined with other immunotherapies, such as checkpoint inhibitors. Oncolytic Viruses in Combination with Chemotherapy Chemotherapy works systemically, unlike surgical resection or radiotherapy. It remains essential for treating patients with disseminated (widespread) cancer. Because chemotherapy is systemic, it is often combined with oncolytic viruses (OVs), which typically require localized delivery to achieve a strong antitumor effect. Systemically administered OVs have shown limited therapeutic benefit in several clinical trials. Delivering OVs effectively to metastatic sites remains a major challenge. Therefore, using chemotherapy as a systemic adjuvant to localized OV therapy is of significant clinical interest and is currently being actively investigated. Oncolytic Virus Market Analysis: Drug Profile IMLYGIC: Amgen IMLYGIC (talimogene laherparepvec), developed by Amgen, is a first-of-its-kind oncolytic viral therapy for melanoma that cannot be surgically removed. It combines direct tumors destruction with immune system stimulation. The therapy is based on a genetically engineered herpesvirus engineered to preferentially infect and destroy cancer cells, releasing GM-CSF to trigger a broader anti-tumor immune response. In the Phase III OPTiM trial, IMLYGIC produced durable responses in about 16% of patients, compared with 2% with GM-CSF alone, and overall responses in roughly 26%. Patients at earlier disease stages achieved better outcomes, with some achieving long-term control. The treatment is usually well tolerated, with most adverse effects being mild and resembling flu symptoms. Although its independent effect on survival and deep organ metastases is modest, its value is most evident when combined with checkpoint inhibitors. Early data show response rates approaching 56%, and ongoing studies aim to further define these synergistic benefits. As the first FDA-approved oncolytic virus in the West, IMLYGIC has validated the broader concept of viral immunotherapy and is now being explored as a component of combination immuno-oncology approaches. Oncorine: Shanghai Sunway Biotech Oncorine, also known as H101, is a genetically engineered adenovirus with an E1B gene deletion developed by Shanghai Sunway Biotech in China. It is administered alongside chemotherapy to treat nasopharyngeal carcinoma and head and neck cancers. Its approval and effective clinical use have significantly advanced oncolytic virus–based cancer immunotherapy. Marketed as Recombinant Human Adenovirus Type 5 Injection, Oncorine became the first oncolytic virus approved for cancer treatment by the Chinese State Food and Drug Administration (CFDA) in November 2005. Since its introduction, it has demonstrated a favorable safety profile and notable antitumor activity across various cancers and malignant pleural effusions. Exploratory clinical studies have also evaluated Oncorine for treating liver cancers, pancreatic cancer, cervical cancer, malignant melanoma, and metastatic liver tumors. Find out more about oncolytic virus cancer drugs @ Oncolytic Virus Analysis A snapshot of the Pipeline Oncolytic Virus Drugs mentioned in the report: Learn more about the emerging oncolytic virus therapies @ Oncolytic Virus Clinical Trials Recent Developments in Oncolytic Virus Treatment Space In November 2025, Imugene Ltd and JW Therapeutics announced a co-development collaboration to evaluate the combination of Imugene's oncolytic virus CF33-CD19 (onCARlytics) and JW's Carteyva®, a CD19-directed autologous CAR-T cell therapy, for patients with advanced solid tumors. This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase I investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene's CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies, a transformative "mark and kill" strategy. In July 2025, Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company's allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. In June 2025, Oncolytics Biotech presented a poster demonstrating the role of pelareorep in activating anti-tumor immunity in PDAC. In May 2025, Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company's biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. In May 2025, Elicera Therapeutics AB announced that it had entered into a Material Transfer Agreement (MTA) with University Hospital Tübingen in Germany. Under the agreement, the company's oncolytic virus candidates ELC-100 and ELC-201 will be included in tests aimed at developing a new type of companion diagnostic to predict the potential success of a novel neuroendocrine neoplasm (NEN) therapy, immuno-virotherapy. In April 2025, Hangzhou ConVerd Co., Ltd. announced that the first Phase IIa clinical study of hV01, ConVerd's first oncolytic vaccinia virus product, had successfully completed first patient dosing, with the subject in good condition. This phase IIa clinical study investigates the administration of a single dose of recombinant human IL-21 oncolytic poxvirus injection (hV01) per cycle for the treatment of patients diagnosed with advanced sarcoma and cervical cancer. It is important to note that the indication is for advanced sarcoma and recurrent or metastatic cervical cancer for which there is no standard of care available at this stage of the treatment process, or where standard of care has failed. Scope of the Oncolytic Virus Pipeline Report Coverage: Global Key Oncolytic Virus Companies: Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others Key Oncolytic Virus Pipeline Therapies: Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others Dive deep into rich insights for new oncolytic Virus treatments, visit @ Oncolytic Virus Drugs Table of Contents Related Reports Oncolytic Virus Therapies Market Oncolytic Virus Therapies Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key oncolytic virus therapies companies including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, and others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, and others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies, including Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris, Biotherapeutics , and others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

免疫检查点抑制剂（ICIs）在肝细胞癌的免疫治疗中已取得显著进展，基于ICIs的免疫联合治疗在肝细胞癌围手术期的应用正逐渐增多。为帮助临床医师更加合理、有效、安全地使用免疫联合治疗方案，国际肝胆胰协会中国分会肝胆胰MDT专业委员会、中华医学会外科学分会肝脏外科学组、中国老年医学学会普外科分会及《中华消化外科杂志》编辑委员会组织多学科专家团队制订《肝细胞癌围手术期免疫治疗多学科协作专家共识（2025版）》。该共识聚焦基于ICIs的免疫联合疗法在肝细胞癌围手术期应用的原则和方法，结合最新研究进展，总结归纳临床推荐意见，旨在为肝细胞癌治疗相关领域专业人员提供依据。 根据世界卫生组织发布的2020 年全球癌症数据，原发性肝癌在全球恶性肿瘤排名中发病率排名第5 位，病死率排名第3 位，病死率与发病率之比为0.91，每年大约有90.6 万原发性肝癌新发病例，造成83 万人病死。肝细胞癌（hepatocellular carcinoma，HCC）是最常见的肝癌类型，约占所有原发性肝癌的80%，大多数HCC 发生在患有病毒性肝炎、非酒精性脂肪性肝病和酒精性肝病等慢性肝病患者中。因此，在许多情况下，HCC 的发生与特征明确的致病危险因素（乙型肝炎病毒、黄曲霉素）和不良生活习惯（吸烟、酗酒）等密切相关。 HCC 的治疗方案取决于疾病的分期。在极早期或早期阶段，最有效的治疗选择仍然是手术切除、肝移植和局部治疗。然而，由于HCC 患者早期通常无症状，当出现肝区疼痛、黄疸、腹水和肝衰竭等典型症状时，患者已经处于中晚期阶段。中期HCC 可以通过经导管动脉化疗栓塞或经导管动脉放射栓塞治疗达到有效的疾病控制，而晚期HCC 则以索拉非尼等分子靶向药物系统治疗为主。尽管传统的HCC 治疗手段不断取得进展，但术后高复发率和对化疗或分子靶向药物的耐药性仍需要开发其他有效的治疗方法。 近年来，随着分子生物学和肿瘤免疫学的发展，科学家们认识到癌症不仅是一种细胞病理性疾病，也是一种免疫功能性疾病。随着肿瘤进展，肿瘤细胞可以上调细胞表面的免疫抑制性蛋白，分泌多种趋化因子、细胞因子以及代谢产物，募集并驯化多种免疫细胞，从而形成具有酸性、缺氧、高压的环境以及低免疫原性和免疫细胞功能障碍等特征的高度免疫抑制性肿瘤微环境，促进肿瘤细胞的生长、转移和治疗抵抗。基于这一过程，目前的HCC 免疫疗法主要倾向于靶向程序性死亡受体-1（programmed cell death protein-1，PD-1）及其配体PD-L1，以逆转肿瘤微环境的免疫抑制状态，促进T 细胞的抗肿瘤免疫反应，从而发挥抗肿瘤作用。因此，以免疫为基础的策略作为肝癌患者新的和潜在有效的治疗支柱开始受到关注。本文将对HCC 免疫治疗的研究现状与进展进行概述。一、免疫检查点抑制剂（immune checkpoint inhibitor，ICI） ICI 是一种通过阻断负性免疫刺激分子，来达到促进和上调T 细胞的启动和活化以释放抗肿瘤活性的药物。PD-1 和PD-L1 是目前最熟悉以及应用最广泛的靶点。PD-L1 是PD-1 的主要配体之一，在包括肿瘤细胞在内的多种细胞上表达。当PD-1与PD-L1 结合时，PD-1 受体胞内段的酪氨酸开关基序发生磷酸化并招募Src 同源区域2 结构域的磷酸酶-2，随后磷酸酶对TCR 下游的信号蛋白去磷酸化，从而抑制T 细胞的激活、增殖和细胞毒性作用。此外，PD-L1 的表达水平越高，HCC 分化程度越低，血管侵犯越多，生存期越短。因此，可以通过ICI 阻断PD-1 或PD-L1，重新激活T 淋巴细胞对肿瘤的攻击能力。然而，由于ICI 单药治疗应答率低，越来越多的临床研究通过将ICI 与其他治疗方式联合以取得了更好的治疗效果。1.1 ICI联合抗血管内皮生长因子单抗 在2020 年IMbrave150 Ⅲ期临床试验的研究结果中，阿替利珠单抗联合贝伐珠单抗组合在中位总生存期（overall survival，OS）、中位无进展生存期（progression free survival，PFS）以及总体缓解率（overall response rate，ORR）等多个临床终点方面显著优于索拉非尼，由此拉开了免疫联合疗法治疗HCC 的序幕。随后，由我国开展的ORIENT-32 研究结果显示，信迪利单抗联合贝伐珠单抗生物类似药组患者的中位PFS（4.6 个月vs.2.8 个月）和中位OS（未达到vs.10.4 个月）均显著长于索拉非尼组患者，并且具有可接受的安全性特征。这些研究表明ICI 联合抗血管内皮生长因子单抗治疗不同地区、不同病因的HCC 患者均具有稳定、满意的疗效。1.2 ICI联合分子靶向药物 COSMIC-312 研究是第一个旨在评估酪氨酸激酶抑制剂联合ICI 双药系统全身治疗晚期肝癌一线患者的Ⅲ期随机对照试验。与索拉非尼相比，卡博替尼联合阿替佐珠单抗的组合疗法与索拉非尼相比虽然维持了PFS 的优势，但并不能改善OS。同样，在随后的LEAP-002 研究中，与乐伐替尼相比，帕博利珠单抗联合乐伐替尼对OS 和PFS 的改善也没有达到预先指定的意义。值得注意的是，我国在2024 年ASCO 会议公布的CARES-310 研究最新数据显示，阿帕替尼联合卡瑞利珠单抗（“双艾组合”）中位OS 达到了惊人的23.8 个月，较索拉非尼组延长8.6 个月。联合组的3 年生存率和ORR 达到了37.7%和26.8%。中位缓解持续时间为17.5 个月。显示了双艾组合与索拉非尼相比在OS、PFS 和ORR 等多个终点上的获益。基于这项研究，我国《原发性肝癌诊疗指南（2024 年版）》已将卡瑞利珠单抗联合阿帕替尼批准用于不可切除或转移性肝癌患者的一线治疗。1.3 双免疫检查点抑制剂 HIMALAYA 研究中，替西木单抗联合度伐利尤单抗的中位OS 为16.43 个月，而索拉非尼组为13.77 个月。在ORR 方面，联合组较对照组提高了3 倍（20.1% vs.5.1%），中位缓解持续时间长达22.3个月，4 年OS 率为25.2% vs.15.1%，并且未出现严重治疗相关不良事件。该方案已被美国FDA、欧盟和日本批准用于治疗不可切除的肝癌患者，但该方案尚未在我国得到批准。在今年的ASCO 会议中报道的CheckMate 9DW 研究结果显示，与索拉非尼或仑伐替尼相比，纳武利尤单抗联合伊匹木单抗（“O+Y 方案”）显著改善了患者的OS，O+Y 组的中位OS 在中期结果达到23.7 个月，而对照组为20.6个月，显示出统计学意义的改善。联合组ORR 显著高于对照组（36% vs.13%），中位缓解持续时间达到30.4 个月，远超对照组的12.9 个月，且未出现新的安全性信号。目前，多项针对不可切除肝癌的一线治疗的ICI 联合疗法的临床研究正在进行中，其结果值得期待。二、嵌合抗原受体（chimeric antigen receptor，CAR）T细胞疗法 CAR T 细胞疗法是一种通过将体外激活和自体扩增的CD8+细胞毒性T 淋巴细胞经过基因工程改造后重新输入到患者体内，来靶向恶性肿瘤的免疫治疗方法。CAR 通常由胞外结构域、铰链区、跨膜结构域和胞内信号传导区域四部分组成，胞外结构域通常是靶向特定的肿瘤抗原的单链抗体，是CAR 设计中最关键的部分，因为它能够使T 淋巴细胞特异性地识别并清除肿瘤细胞。 磷脂酰肌醇蛋白聚糖3（glypican 3，GPC3）是一种锚定在细胞膜上的跨膜蛋白，在肝癌中特异性高表达，而在正常成人组织中几乎不表达，这使其成为肝癌中具有特异性和吸引力的靶点。Gao 等首次发现靶向GPC3 的CAR-T 细胞的抗肿瘤效果与GPC3 的表达成正比，并通过动物实验发现第三代靶向GPC3 的CARs 来源的T 细胞可以清除高表达GPC3 的肝癌移植瘤。随后，Fu 等利用第四代CAR-GPC3 T 细胞CT017 单药和与酪氨酸激酶抑制剂联合治疗晚期HCC，显示出可控的安全性和可行性。重治疗晚期HCC 患者的中位OS 和中位PSF 分别为7.9 个月和3.5 个月，最长OS 为18.2 个月。除GPC-3 外，用于治疗HCC 的CAR-T 靶抗原还包括甲胎蛋白（alpha fetoprotein， AFP）、CD147、CD133、上皮细胞黏附分子（epithelial cell adhesion molecule，EpCAM）等。针对这些靶点的CAR-T细胞在基础研究中也展现出不错的效果。由于HCC中肿瘤抗原表达具有异质性，靶向多种肿瘤相关抗原（tumor associated antigen，TAA）可能是一种有效的策略。然而，TAA 在正常组织中也有低水平表达，这可能会引起靶向毒性。此外，CAR-T 细胞输回患者体内后如何维持增殖和活化，克服CAR-T 细胞耗竭问题，也是需要深入研究的问题。针对CAR-T 细胞上的免疫检查点进行基因编辑，并结合靶向药物抑制肿瘤免疫抑制微环境可能会有效。三、溶瘤病毒（oncolytic viruse，OV）和肿瘤疫苗 OV 疗法是一种利用野生型或基因工程病毒在肿瘤细胞中选择性复制并裂解肿瘤细胞而不伤害正常细胞的治疗方法。由于癌细胞较正常细胞对应激、细胞信号传导和稳态反应的级联信号反应存在异常，这些变化为病毒在肿瘤细胞中选择性复制提供了天然优势。OV 还能够诱导不同类型的免疫原性细胞死亡，破坏肿瘤血管生成，诱导机体产生抗肿瘤免疫反应并通过多种机制调节肿瘤微环境，使冷肿瘤转化为热肿瘤。肿瘤疫苗可以通过引入特定的TAA 或肿瘤特异性抗原来诱导抗肿瘤反应。根据TAA 表达形式的不同，可将肿瘤疫苗分为病毒载体疫苗、多肽疫苗、细胞疫苗和核酸疫苗。 JX-594 是一种重组溶瘤牛痘病毒，它可以特异性地裂解肿瘤细胞并释放粒细胞-巨噬细胞集落刺激因子来激活特异性抗肿瘤免疫反应。JX-594联合索拉非尼的Ⅲ期临床试验（NCT02562755）于2020 年完成，初步结果显示联合治疗大多耐受性良好。然而，在这项研究中，JX-594 并不能改善总生存率而被提前终止。VG161 是一种携带白细胞介素（interleukin，IL）-12、IL-15 及其受体α 单元和PD-L1 肽段阻断剂基因的新型单纯疱疹病毒1 型OV。从2023 年11 月起，研究者开展了一项针对晚期HCC 的Ⅰb/Ⅱa 期临床试验（NCT06124001），以评估VG161 联合卡瑞珠单抗治疗晚期原发性HCC 患者的疗效、安全性和患者的耐受程度。此外，针对HCC 多个OV 相关的候选治疗药物正处于临床和临床前阶段。AFP 是胚胎发育过程中卵黄囊和胎肝产生的主要血浆蛋白，在胎儿出生后AFP 水平迅速下降，而在大多数HCC 肿瘤中重新表达。因此，AFP 在临床上可以作为HCC 的一个有前途的潜在靶点。一项研究表明，在AFP（+）HCC 小鼠模型中，AFP 疫苗与抗PD-L1 治疗相结合，在大多数肝肿瘤结节中引发了HCC 进展的显著抑制。目前，肿瘤疫苗跟OV 对于中晚期HCC 患者并没有太大的获益，但由于其独特的作用机制以及HCC 特殊的肿瘤微环境，随着未来生物学技术的发展，肿瘤疫苗跟OV 可能有很大的应用前景。四、结语 在过去，癌症的免疫疗法取得了显著的进展，并显示出肝癌治疗的巨大潜力。与传统的治疗方法相比，免疫疗法通过激活患者自身的免疫系统来对抗肿瘤，并伴随较少的副作用。然而，仅部分患者能对免疫疗法产生反应，部分原因是肿瘤微环境中的多种免疫抑制机制相互作用干扰了免疫反应的正常运行。在这种情况下，了解HCC 的致癌途径和免疫反应之间的关联以及免疫疗法可预测生物标志物对于增强当前和未来疗法的功效至关重要。目前，针对HCC 的免疫治疗研究正在积极进行，以评估它们作为单一疗法或与其他治疗方法联合应用的效果。然而，不同药物之间的组合效果并非总是预期的简单相加或协同作用，这要求我们对不同的药物组合进行细致的研究，以确定最佳的治疗方案。     贾晓周，毕业于河北医科大学，中西医结合、临床医学双学历，后于辽宁中医药大学附属医院进修，曾就职于辽宁航空航天附属医院，曾受聘于北京至道中医研究院任副院长，重庆慢性呼吸系统病防治中心会诊专家、国家生活方式医学领域专家顾问，传统武式太极拳精英传承人，世界医疗健康管理协会会员，长年从事创新性医药领域及临床诊疗技术应用学术研究工作。    目前主要从事呼吸领域相关疾病临床诊疗进展、儿童生长发育及慢性骨病中西医联合诊疗领域科研工作，国内外先进特色诊疗技术挖掘及整理。曾参加中国咳嗽诊疗指南万里行巡讲，作为“气道炎症专场”特邀专家，2018年发起“中国基层咳嗽诊疗指南万里行”活动，2020年发起“中国基层儿童咳喘病全国巡讲”活动，2021年发起“中国基层慢病规范化诊治”全国巡讲活动，2023年新冠病毒感染及其并发症的临床规范化诊治方案更新，推进基层《新冠感染咳嗽专科门诊》、《呼吸慢病专科门诊》等专科门诊机构的建立，2025年进行关于儿童生长发育及慢性骨病中西医临床最新诊疗模式进展探究，深入研究“疏木六君子汤”在神经内分泌肿瘤领域的应用进展，进一步提升最新生物制剂相关特效雾化治疗方案相关难治性、难愈性呼吸系统疾病治疗，推进基层“气道炎症计”呼出气一氧化氮精准化气道炎症水平测定及指导相关呼吸系统疾病中西医结合治疗方案。立足于目前临床最新医学进展领域：阶梯式治疗方案、呼吸免疫治疗方案、上下气道同治治疗方案、精准化诊治治疗方案、常见病快速评估等及针对中西医结合临床一线指南推荐用药等做全面总结研究，以帮助更多的同仁完成科学、精准、规范的诊治，开展更多医疗领域学术交流会议，推进常见多发病的预防、科学的健康管理新理念。