Neoantigen Vaccines in Combination with Immune Checkpoint Inhibitors for Maintenance Therapy Following Definitive Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: an Open-Label, Randomized, Phase II Study

The aim of this clinical trial is to evaluate the efficacy and safety of consolidation therapy with a neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) following radical chemoradiotherapy or chemoradiation-immunotherapy in patients with locally advanced, unresectable ESCC. The primary endpoint of the study is the OS rate. Secondary endpoints include OS, PFS, adverse events, CR rate, and quality of life (QoL) of patients. Exploratory endpoints involve the assessment of biomarkers such as TMB, PD-L1, and ctDNA.
The key questions this study aims to answer are:
-Can the combination of (ICIs and NeoDC-Vac as maintenance therapy improve OS and QoL in patients with locally advanced, unresectable ESCC following radical treatment? Can this novel approach provide an effective treatment option for these patients?
Participant Procedures:
1. Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.
2. Screening assessments, informed consent, and random assignment to experimental or control group.
Experimental Group**: Neoantigen-loaded vaccine + standard ICIs as maintenance therapy.
Control Group**: Standard ICIs as maintenance. One cycle per month for one year.
3. Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.
4. After completing the full treatment regimen, participants will be monitored with regular follow-up visits by healthcare professionals to assess ongoing health outcomes and safety.

开始日期2024-10-01

申办/合作机构

四川大学

NCT06329908

/ Recruiting早期临床1期IIT

Single-arm, Open, Prospective Clinical Study of Neoantigen-loaded Dendritic Cell Vaccine (Neo-DCVac) Combined With Immune Checkpoint Inhibitors (ICIs) in the Treatment of Advanced Lung Cancer Resistant to ICIs

This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.

开始日期2023-09-27

申办/合作机构

四川大学

NCT05317325

/ Unknown status临床1期IIT

A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC

开始日期2022-04-01

申办/合作机构

四川大学

100 项与 OCDC vaccine(Sichuan University) 相关的临床结果

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100 项与 OCDC vaccine(Sichuan University) 相关的转化医学

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100 项与 OCDC vaccine(Sichuan University) 相关的专利（医药）

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项与 OCDC vaccine(Sichuan University) 相关的文献（医药）

2020-04-01·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy2区 · 化学

AND logic gate based fluorescence probe for simultaneous detection of peroxynitrite and hypochlorous acid

2区 · 化学

Article

作者: Guansheng Zheng ; Yin Jiang ; Zejun Li ; Derek Ho ; Yongguang Jia ; Yong He ; Huatang Zhang ; Qinya Duan ; Shumei Huang ; Lili Cai

Hypochlorous acid (HOCl) and peroxynitrite (ONOO^-) are two of the most important reactive species and associated with various diseases in various physiological and pathological processes. Nonetheless, many of their roles are still vague due to the shortage of methods for simultaneously detecting HOCl and ONOO^-. Herein, three simple yet useful fluorogenic probes, LG-1, LG-2 and LG-3, have been fabricated with facile synthesis route and used to monitor the coexistence of HOCl and ONOO^- as AND-based logic gate fluorescent probe firstly. LG-1 and LG-2, which consists of 1,3-oxathiolane group and boronate group respectively, were designed to verify the capacity of monitoring HOCl and ONOO^- without interference from each other. The result showed that these two groups are perfect reaction sites of detecting HOCl and ONOO^- respectively via specific analyte-induced reactions. Hence, LG-3, which is attached by these two groups to suppress the fluorophore core, can response to HOCl and ONOO^- simultaneously without mutual interference and generate the significant time-dependent fluorescence enhancement. By investigating the absorption and fluorescence properties of LG-3 towards HOCl and ONOO^- individually and collectively, the result confirmed clearly that LG-3 has the capacity of monitoring the coexistence of HOCl and ONOO^-, which could act as a two-input AND-based logic gate fluorescent probe.

2017-02-01·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[Imiquimod combined with dendritic cell vaccine decreases Treg proportion and enhances anti-tumor responses in mice bearing melanoma].

Article

作者: Li, Ping ; Ren, Shurong ; Lu, Cuixiu ; Wang, Qiubo ; Zhang, Yanli ; Li, Yumei

Objective:

To investigate the therapeutic effect of Toll-like receptor 7( TLR7) agonist imiquimod combined with dendritic cell( DC)-based tumor vaccine on melanoma in mice and the potential mechanism.

Methods:

Melanoma-bearing mouse models were established by subcutanous injection of B16-OVA cells into C57 BL /6 mice. DCs were isolated from mouse bone marrow and propagated in culture medium with recombinant mouse granulocyte-macrophage colony-stimulating factor( rm GM-CSF) and recombinant mouse interleukin-4( rm IL-4). DC vaccine( OVA-DC) was prepared by overnight incubation of DCs added with chicken ovalbumin. C57 BL /6 mice were separated into four groups which were treated with PBS,topical imiquimod application,OVA-DC intradermal injection and imiquimod plus OVA-DC,respectively. The tumor size was calculated by digital vernier caliper. Peripheral blood CD4~+FOXP3~+Tregs of the tumor-bearing mice was detected by flow cytometry. The cytotoxicity of splenic lymphocyte against B16-OVA was assessed in vitro by CCK-8 assay.

Results:

Compared with the other three groups,B16-OVA-bearing mice treated with imiquimod plus DC vaccine had the smallest tumor volume. The percentage of CD4~+FOXP3~+Tregs decreased significantly in the combined treated mice. The combined treatment enhanced significantly cytotoxicity of splenic lymphocytes against B16-OVA cells.

Conclusion:

Imiquimod combined with antigen-pulsed-DC vaccine could reduce CD4~+FOXP3~+Treg proportion and promote anti-tumor effect in mice with melanoma

Anticancer research4区 · 医学

Combination therapy with tumor cell-pulsed dendritic cells and activated lymphocytes for patients with disseminated carcinomas.

4区 · 医学

Article

作者: Onishi, Hideya ; Matsumoto, Kotaro ; Nakamura, Mitsunari ; Koga, Kennichiro ; Morisaki, Takashi ; Nakashima, Hiroshi ; Akiyoshi, Takashi ; Tasaki, Akira ; Nakamura, Masafumi ; Katano, Mitsuo

This phase I study was performed to assess the safety and immune response of tumor cell-pulsed dendritic cell (DC) vaccine therapy against cancer patients with multiple metastases. DCs, generated from adherent cells of peripheral blood mononuclear cells (PBMCs) using interleukin-4 (IL-4) and granulocyte/monocyte colony-stimulating factor, were loaded with autologous necrotic whole tumor cells. Thereafter, the DCs were matured with culture supernatants of OK-432-stimulated PBMCs. Activated lymphocytes were also induced from non-adherent cells of PBMCs using OKT-3 and IL-2. Patients received a subcutaneous injection of DCs loaded with tumor cells every 2 weeks and received an intravenous injection of activated lymphocytes every 4 weeks. This combination therapy was named tumor-pulsed DC vaccine therapy. Tumor-pulsed DC vaccine therapy was continued as long as possible in 19 patients. No particular adverse reactions, except for low-grade fever, were found. The patients could be divided into two groups according to the survival time, i.e., 6 responders (long survival patients) and 13 non-responders (short survival patients). Based on the laboratory data of responders, eligibility criteria were determined. Using the eligibility criteria, a phase I/II study was recently performed with 15 patients. A delayed-type hypersensitivity reaction against tumor-pulsed DCs became positive in 13 of the 15 patients within 6 months after the therapy. This therapy was again safe, and no evidence of autoimmune disease was noted. The survival time of these 15 patients was significantly prolonged compared with that of the 13 non-responders of the phase I study (p < 0.0001). This continuous tumor-pulsed DC vaccine therapy was well tolerated in patients with disseminated carcinomas.

项与 OCDC vaccine(Sichuan University) 相关的新闻（医药）

2025-03-03

·今日头条

国研新型DC疫苗Neo-DCVac震撼登场：近半数肺癌患者肿瘤缩小

肿瘤新抗原因具有高度的肿瘤特异性和免疫原性，被认为是肿瘤免疫治疗的终极靶点。基于肿瘤新抗原的树突状细胞（DC）疫苗犹如一把精准的“免疫钥匙”，有望开启肿瘤治疗的全新大门，为广大癌友带来新的曙光！近期，我国医疗科研团队携手奋进，华西医院和同济大学附属第十人民医院强强联合，共同开展的一项“ 应用基于肿瘤新抗原的树突状细胞（DC）疫苗，治疗晚期肺癌 ” 的先导研究（NCT02956551）。其惊艳数据一经公布，便在业界引起了广泛关注，瞬间点燃了肺癌治疗领域的新希望之火！ ▲截图源自“PMC” 一、个性化新抗原脉冲DC细胞疫苗Neo-DCVac，推动近半数肺癌患者肿瘤大幅缩小，疾病控制率高达75% 肺癌是世界上发病率和死亡率最高的恶性肿瘤。尽管近年来肺癌的靶向治疗和免疫检查点抑制剂发展迅速，但总体而言其疗效仍不令人满意。因此，肺癌治疗存在迫切的未满足的临床需求。目前，手术和根治性放化疗仍是早期肺癌的标准治疗方法。2对于晚期患者，靶向治疗药物和免疫检查点抑制剂（ICI）等药物治疗明显改善了部分患者的预后。然而，对于一线治疗失败的晚期患者，治疗选择有限，预后不佳。因此，复发性晚期患者的治疗主要目标是延长生存期、缓解症状、提高生活质量，亟待开发新型、有效、低毒的治疗方法。华西医院和同济大学附属第十人民医院联合开展的这项研究，无疑为肺癌患者带来了新的希望！本次研究共纳入18例（华西医院15例、同济大学附属第十人民医院3例）在标准多线治疗下复发的晚期肺癌患者，最终12例患者入组接受Neo-DCVac疫苗（即个性化新抗原肽脉冲自体DC疫苗）治疗，中位数为5剂/人（范围：3～14剂/人），每例患者共选择12～30种肽基肿瘤新抗原。结果显示：所有治疗相关不良事件均为1～2级，无毒性作用导致给药延迟。中位无进展生存期（PFS）为5.5个月（95%Cl，1.9–9.2）（详见下图b），中位总生存期（OS）为7.9个月（95% CI, 5.9–10.0）（详见下图c）。 ▲图源“Signal Transduct Target Ther”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除此外， 12 例患者中有3例 (25%) 达到客观缓解，客观缓解率（ORR）为25% （详见下图）。疾病控制率（DCR）达到75%（9/12）。 50%（6/12）的患者出现靶病变缩小。 ▲图源“Signal Transduct Target Ther”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除值得一提的是，其中两例患者（患者1、患者17）值得特别关注。患者 1 是一名 72 岁的转移性肺腺癌男性，在三线化疗和放疗失败后，随后入组并接受了个体化 Neo-DCVac 治疗。结果显示：在一轮 Neo-DCVac 治疗后，复查计算机断层扫描(CT)显示，该患者原发性肺肿瘤达到部分缓解（PR）（详见下图）。 ▼患者1在在五剂个性化Neo -DCVac疫苗治疗前、治疗后的计算机断层扫描（CT）对比图 ▲图源“Signal Transduct Target Ther”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除患者17是一患有广泛期肺腺癌的男性，主要转移位于骨、盆腔、肾上腺和下腔静脉淋巴结。该患者既往曾接受包括PD-1抑制剂（纳武单抗）在内的三线疗法失败后，遂入组接受Neo-DCVac疫苗回输治疗。结果显示：在接受五剂Neo-DCVac治疗后，转移性淋巴结几乎消失，肾上腺和盆腔转移病灶缩小（详见下图）。总体而言，他的肿瘤靶病灶减少了29％，该患者达到了病情稳定（SD）。 ▲图源“Signal Transduct Target Ther”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除二、新抗原疫苗颠覆传统，重塑癌症治疗格局近年来，免疫治疗领域不断突破，为癌症治疗带来了新的希望。免疫检查点抑制剂成功激活新抗原特异性 T 细胞，过继性新抗原反应 T 细胞疗法也取得了突破性进展，这些成果共同推动治疗性癌症疫苗的研发迎来关键转折点。它们揭示了免疫系统识别肿瘤特异性抗原的核心机制，为癌症免疫治疗开辟了全新的路径，使我们对利用免疫系统对抗癌症有了更深入的理解。在癌症免疫治疗中，新抗原被视为理想靶标，具有三大突出优势： 1、它源于肿瘤特异性体细胞突变，具有高度的肿瘤特异性，能够精准地将癌细胞与正常细胞区分开来； 2、新抗原不受中枢免疫耐受机制的影响，因而具备显著的免疫原性，能够有效激发免疫系统对癌细胞的攻击； 3、新抗原呈现出显著的个体化特征，这为精准医疗奠定了坚实的分子基础，使得针对每位患者的个性化治疗成为可能。正是这些特性，有力地推动了个体化新抗原疫苗的迅速发展，逐渐重塑着癌症治疗的整体格局。癌症免疫治疗的核心在于巧妙借助患者自身的免疫系统，实现对癌细胞的精准、选择性破坏。其中，诱导强效的 T 细胞介导免疫应答是关键策略。癌症疫苗作为重要的免疫调控手段，通过增强免疫系统对肿瘤抗原的识别敏感性，与现有疗法协同作用，显著提升了整体治疗效果，为癌症患者带来了更多的生存希望。三、小编寄语癌症疫苗作为癌症治疗领域的新兴力量，历经数十载的发展，展现出了巨大的潜力和前景。随着研究的不断深入和技术的不断进步，我们有理由相信，癌症疫苗将在未来的癌症治疗中，发挥越来越重要的作用，还可与手术、化疗、放疗、免疫治疗等传统治疗手段相结合，形成综合治疗方案，为肿瘤患者带来更高的生存获益！小编也期望随着癌症疫苗的不断优化，未来可以创造出更多的抗癌奇迹！四、参考资料 [1]Ding Z,et al.Personalized neoantigen pulsed dendritic cell vaccine for advanced lung cancer. Signal Transduct Target Ther. 2021 Jan 20;6(1):26. https://pmc.ncbi.nlm.nih.gov/articles/PMC7817684/ 本文为全球肿瘤医生网原创，未经授权严禁转载

疫苗临床结果

100 项与 OCDC vaccine(Sichuan University) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
食管鳞状细胞癌	临床2期	中国	四川大学	2024-10-01
局部晚期食管鳞状细胞癌	临床2期	中国	四川大学	2024-10-01
不能切除的食管鳞状细胞癌	临床2期	中国	四川大学	2024-10-01
膀胱癌	临床1期	中国	四川大学	2022-03-01
结直肠癌	临床1期	中国	四川大学	2022-03-01
IV期恶性黑色素瘤	临床1期	中国	四川大学	2022-03-01
非小细胞肺癌	临床1期	中国	四川大学	2016-11-30

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适应症

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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


NCT05023928 (AACR2024) 人工标引	临床1期	食管鳞状细胞癌辅助	12	personalized neoantigen DC vaccines (Neo-DCVac)	壓鏇餘蓋夢艱獵網膚構(繭構鬱願選衊餘憲醖糧) = 衊網顧鏇鹹壓壓鑰簾鑰鏇鹹製顧蓋觸襯觸範遞 (廠窪夢夢簾夢選鏇衊淵 ) 更多	积极	2024-03-22
NCT05023928 (AACR2024) 人工标引	临床1期	食管鳞状细胞癌辅助	12	personalized neoantigen DC vaccines (diver genes)	遞鹽製築製鏇襯衊齋鑰(構夢遞鬱醖鹽製選鹹範) = 憲獵選範觸糧選製壓醖觸廠襯夢獵艱願觸憲窪 (遞觸醖糧遞糧蓋築獵鏇 )	积极	2024-03-22
NCT02956551 \| ChiCTR-ONC-16009100 (Pubmed \| NEWS \| Signal Transduct Target Ther) 人工标引	临床1期	非小细胞肺癌	12	DC vaccine(Sichuan University)	壓齋製顧繭膚艱鹹膚廠(餘蓋憲艱壓醖壓鏇選願) = 艱膚獵糧淵襯憲願窪憲餘鏇顧醖構積衊膚艱鑰 (範鏇憲醖選鹹構顧積衊 ) 更多	积极	2021-01-20