Cancer vaccine(Therion Biologics Corp.)(Cancer vaccine(Therion Biologics Corp.)) - 药物靶点：CEACAM5 x MUC1_在研适应症：非小细胞肺癌，前列腺癌，局部晚期胰腺腺癌_专利_临床

概要

基本信息

药物类型

重组载体疫苗、治疗性疫苗

别名

cancer vaccines(Bavarian Nordic/National Cancer Institute)、CEA-MUC-1-TRICOM Vaccine、CEA-MUC-1/TRICOM

+ [11]

靶点

CEACAM5 x MUC1

作用方式

拮抗剂、抑制剂、刺激剂

作用机制

CEACAM5拮抗剂(癌胚抗原相关细胞粘附分子5拮抗剂)、MUC1抑制剂(黏蛋白-1抑制剂)、免疫刺激剂

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [2]

在研适应症

非小细胞肺癌前列腺癌局部晚期胰腺腺癌+ [2]

非在研适应症

大肠腺癌晚期癌症乳腺癌+ [14]

原研机构

Therion Biologics Corp.

在研机构

National Cancer InstituteBavarian Nordic, Inc.

非在研机构

Bavarian Nordic A/S

Therion Biologics Corp.

MedImmune LLC

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

登录后查看时间轴

关联

13

项与 Cancer vaccine(Therion Biologics Corp.) 相关的临床试验

NCT04574583

/ Completed临床1/2期IIT

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

Background:
Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors.
Objective:
To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink.
Eligibility:
Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial.
Design:
Participants will be screened under a separate protocol.
Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart.
Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers.
Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary.
Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.

开始日期2020-11-24

申办/合作机构

National Cancer Institute

NCT04491955

/ Completed临床2期IIT

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers cannot be cured and are often not helped by standard treatments. Researchers want to find better treatments by testing a combination of drugs.
Objective:
To learn if a new combination of immunotherapy drugs can shrink tumors in people with advanced small bowel and colorectal cancers.
Eligibility:
People ages 18 and older who have advanced metastatic or refractory/recurrent small bowel and/or colorectal cancer.
Design:
Participants will be screened on a separate protocol. They will have a physical exam and medical history. They will have imaging scans. They will have blood and urine tests. Their heart function will be measured. They may have a tumor biopsy.
Participants will repeat some of the screening tests during the study.
Participants will be put into study groups. Each group will get a combination of the following drugs: CV301 vaccine (modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301), M7824 (MSB0011359C), and N-803 (Anktiva). Some will also get NHS-IL12 (M9241).
Participants will get the CV301 vaccines by injection under the skin. They will get M7824 by intravenous infusion every 2 weeks. They will get N-803 by injection under the skin every 2 or 4 weeks. They may get NHS-IL12 by injection under the skin every 4 weeks. They will take the study drugs for up to 1 year. They will visit the National Institutes of Health (NIH) every 2 weeks.
After treatment ends, participants will go to the clinic for a 28-day follow-up visit or have a telephone call. They will be contacted every 3 months for 1 year, and then every 6 months after that for the rest of their life.

开始日期2020-09-22

申办/合作机构

National Cancer Institute

NCT03628716

/ Completed临床2期

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).

开始日期2018-09-18

申办/合作机构

Bavarian Nordic A/S

100 项与 Cancer vaccine(Therion Biologics Corp.) 相关的临床结果

登录后查看更多信息

100 项与 Cancer vaccine(Therion Biologics Corp.) 相关的转化医学

登录后查看更多信息

100 项与 Cancer vaccine(Therion Biologics Corp.) 相关的专利（医药）

登录后查看更多信息

18

项与 Cancer vaccine(Therion Biologics Corp.) 相关的文献（医药）

2026-02-05·ONCOLOGIST

The quadruple immunotherapy for colorectal cancer (QuICC) trial for mismatch repair-proficient metastatic colorectal cancer

Article

作者: Pastor, Danielle M ; Turkbey, Evrim B ; Tschernia, Nicholas P ; Cordes, Lisa ; Marté, Jennifer L ; Karzai, Fatima ; Floudas, Charalampos S ; Redman, Jason M ; Hodge, James W ; Gulley, James L ; Maeng, Hoyoung M ; Brownell, Isaac ; Donahue, Renee N ; Soon-Shiong, Patrick ; Strauss, Julius ; Schlom, Jeffrey ; Bracken-Clarke, Dara

Abstract:

Background:

Despite successes in other malignancies, immune checkpoint blockade (ICB) has not demonstrated reproducible efficacy in mismatch repair-proficient (pMMR) colorectal cancer (CRC). Preclinical studies indicate that multitargeted combination immunotherapy may sensitize resistant tumors to immune-mediated killing. This trial was designed to test this hypothesis by combining agents to induce and augment an immune response in pMMR CRC.

Methods:

In this single-center, phase 1/2 trial, eligible patients had pMMR, RECIST v1.1-measurable metastatic CRC, ≥2 prior lines of therapy, and no prior immunotherapy. The primary endpoint was objective response rate. Patients received triplet therapy: CV-301 (CEA/MUC-1 vaccine), N-803 (IL-15 receptor superagonist), bintrafusp alfa (bifunctional anti-PD-L1/TGFβ “trap”), or quadruplet therapy (adding PDS01ADC [tumor-targeted IL-12 immunocytokine]).

Results:

Between September 2020 and September 2022, 32 patients enrolled in triplet (n = 12) and quadruplet (n = 20) therapy. The combinations had toxicity profiles consistent with each individual agent included. One complete response durable for 29+ months occurred in a patient with RAS wild-type CRC metastatic to lymph nodes who received quadruplet therapy.

Conclusion:

Quadruplet therapy produced one objective response in unselected mCRC patients (n = 20). There were no responses with triplet therapy (n = 12). The role of ICB-based combination immunotherapy in pMMR CRC remains unclear. NCT04491955

2025-11-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer

Article

作者: Dolan, Rebecca ; Navarro, Cesar Pico ; Telfer, Siobhan ; Apolo, Andrea B ; Elsamra, Sammy E ; Agarwal, Piyush K ; Donahue, Renee N ; Schlom, Jeffrey ; Jang, Thomas L ; Saoud, Ragheed ; Singer, Eric A ; Weiss, Robert E ; Stamatakis, Lambros ; Tremblay, Samuel ; Merino, Maria ; Dahmen, Aaron ; Rodriquez, Beatriz Walter ; Ho, Matthew ; Maruf, Mahir ; Bellfield, Sonia ; Gulley, James L ; Railkar, Reema ; Lazarovich, Alon ; Valera, Vladimir ; Shih, Joanna

PURPOSE:

We postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC).

METHODS:

This was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints.

RESULTS:

Our study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival.

CONCLUSIONS:

This phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

2023-03-01·Cancer immunology, immunotherapy : CII

Phase II trial of CV301 vaccine combined with atezolizumab in advanced urothelial carcinoma

Article

作者: Kilbridge, Kerry L ; McGregor, Bradley Alexander ; Montgomery, Robert B ; Cheng, Heather H ; Maughan, Benjamin Louis ; Jain, Rohit ; Wei, Xiao X ; Perschy, Teresa ; Gafoor, Zarina ; Schweizer, Michael Thomas ; Grewal, Jaspreet S ; Lee, Richard J ; Hsieh, Andrew Caleb ; Sonpavde, Guru P ; Grivas, Petros ; Pico-Navarro, Cesar ; Yu, Evan Y

CV301 comprises recombinant poxviruses, Modified Vaccinia Ankara (MVA) and Fowlpox (FPV), encoding CEA, MUC-1, and co-stimulatory Molecules (TRICOM) ICAM-1, LFA-3, and B7-1. MVA-BN-CV301 is used for priming and FPV-CV301 is used for boosting. A Phase 2, single-arm trial was designed to evaluate CV301 plus atezolizumab as first-line treatment for cisplatin-ineligible advanced urothelial carcinoma (aUC) (Cohort 1) or progressing after platinum chemotherapy (Cohort 2). MVA-CV301 was given subcutaneously (SC) on Days 1 and 22 and FPV-CV301 SC from day 43 every 21 days for 4 doses, then tapered gradually over up to 2 years. Atezolizumab 1200 mg IV was given every 21 days. The primary endpoint was objective response rate (ORR). Overall, 43 evaluable patients received therapy: 19 in Cohort 1; 24 in Cohort 2; nine experienced ≥ Grade 3 therapy-related adverse events. In Cohort 1, one had partial response (PR) (ORR 5.3%, 90% CI 0.3, 22.6). In Cohort 2, 1 complete response and 1 PR were noted (ORR 8.3%, 90% CI 1.5, 24.0). The trial was halted for futility. Patients exhibiting benefit demonstrated T-cell response to CEA and MUC-1. The trial illustrates the challenges in the development of vaccines, which should be guided by robust preclinical data.

5

项与 Cancer vaccine(Therion Biologics Corp.) 相关的新闻（医药）

2026-09-03

·微信

晚期肠癌肝转移完全缓解！新型癌症疫苗三联疗法创造重生奇迹！

美国，克利夫兰诊所的一则震撼案例为全球肠癌病友点亮希望：62岁的IV期结直肠癌肝转移M女士，幸运的采用了全球前沿的CV301肿瘤疫苗+纳武利尤单抗免疫治疗+全身化疗三联创新方案，短短4个月，上演惊天逆转：转移病灶完全消退！术后一年无复发、重新回到了正常生活。晚期肠癌成功实现零肿瘤！新型癌症疫苗三联疗法创造重生奇迹！ 62岁那年，M女士因左腹部绞痛和血性腹泻前往美国知名的克利夫兰诊所进行检查。 CT片子出来的那一刻，M女士的世界陷入一片黑暗：肝脏上，一颗；结肠上，一颗。两处肿块，像两记无声的重锤——四期结直肠癌，已经肝转移。在很多人的认知里，"肠癌肝转移"几乎就是一张晚期通知书。然而，她的主治医生、肿瘤专家苏尼尔·卡马斯（Suneel Kamath）博士，没有走"先放化疗拖一拖"的老路。他望着这位本该安享晚年的女性，问出了那句改变结局的话："愿不愿意，赌一把还没几个人试过的前沿疗法？" M女士决定尝试更有希望治愈的疗法。就这样，她成了 HCRN 1218 临床试验的一员：一种把"抗肿瘤疫苗 + 免疫药 + 化疗"三股力量拧成一股绳的全新组合，目标只有一个——先把结肠和肝脏里的肿瘤"打小、打没"，再开刀彻底清扫切除。 4个月后，手术灯亮起。外科医生术中探查发现，患者体内结肠、肝脏的癌细胞已被彻底杀灭，几乎找不到存活的肿瘤组织，原本多发的转移病灶完全消退！ "我们费了好大劲，才找到原来肿瘤待过的位置。"卡马斯医生后来回忆，"它已经彻底消失了。" 术后M女士持续巩固治疗，随访一年有余，全程无复发、无进展，一个原本被贴上"晚期"标签的女人，重新回到了能散步、能陪家人吃饭、能继续过普通日子的生活里。这个真实发生在克利夫兰诊所的故事，不是电影桥段——它背后，是一次让整个医学界都为之振奋的突破：原来连"免疫都治不了"的难治肠癌，也能被一套组合拳，逼到无路可走。疾病控制率高达100%，7名患者实现完全缓解！新型肠癌疫苗CV301交出满分答卷！一直以来，可切除结直肠癌肝转移是临床治疗的重点与难点。传统治疗仅依靠化疗、单纯免疫治疗，存在明显短板：要么杀癌不彻底，残留微小病灶极易复发；要么免疫靶向性不足，对顽固转移癌细胞束手无策，多数患者术后依旧难逃复发转移宿命。为破解这一临床困局，国际多家顶尖肿瘤中心联合发起HCRN 1218 II期重磅临床试验，专门针对可切除肝转移性结直肠癌，创新性搭建「化疗打底+免疫破冰+疫苗精准锁癌」的全新围手术期治疗体系，彻底改写晚期肠癌的治疗格局。这项双臂随机对照临床试验，将入组的17位患者分为两大组别，直观对比疗效差异： ✅ 常规对照组：仅采用传统化疗+纳武利尤单抗免疫治疗； ✅ 创新试验组：在化疗+免疫基础上，叠加CV301专属肿瘤疫苗。区别于普通泛抗癌疗法，CV301疫苗是专门针对结直肠癌研发的靶向疫苗，精准锁定肠癌两大核心标志物CEA、MUC1。普通免疫治疗虽能激活免疫系统，但对肿瘤的识别缺乏特异性，容易出现“杀敌不准、激活不足”的问题；而CV301疫苗的加入，相当于给免疫细胞配备了专属“癌细胞定位器”，精准引导免疫大军靶向击杀结直肠癌细胞，完美弥补传统治疗的短板。美国ASCO大会上公布这项试验的阶段性数据，印证了三联疗法的超强实力，每一组数据都为晚期肠癌患者带来实打实的生存希望！ 🔥 客观缓解率（ORR）高达87.5%，远超常规双药组合的50%，疾病控制率高达100%！超八成患者实现肿瘤大幅缩小、消退，7名患者达到影像学完全缓解，病灶彻底清零； 🔥 病理完全缓解率显著提升，术前新辅助治疗彻底杀灭浸润癌细胞，最大程度清除微小残留病灶，为根治手术扫清所有障碍； 🔥 治疗安全性优异，全程无严重不良反应，副作用轻微可控，患者耐受性极佳，治疗期间可正常生活，彻底告别传统化疗“伤身治病”的困境； 🔥 长效防复发优势突出：疫苗可诱导机体产生长期免疫记忆细胞，术后持续巡逻、精准清除潜在休眠癌细胞，从根源降低晚期患者的高复发风险。正如本次主治医生Suneel Kamath博士所言：这一创新方案的核心价值，不止是缩小肿瘤、完成手术，更能实现根治性灭癌+长效防复发+保全生活质量三重突破，让原本预后极差的晚期转移肠癌，拥有了临床治愈的可能。重磅福音！国内肠癌疫苗落地，普通人也能接轨全球顶尖技术值得振奋的是，咱们自己的国研个性化疫苗等前沿技术，已经正式在先行区落地，想评估国研癌症疫苗及国内外新疗法的病友，可先将病历提交至全球肿瘤医生网医学部 400-666-7998 进行评估。【可申请适配人群】 1. 早中期术后，担心复发、想做免疫巩固的癌症患者； 2. 晚期转移，化疗/靶向/免疫耐药患者； 3. 携带KRAS、CEA、PRAME等靶点突变患者；这位62岁女性的故事，不是要告诉你"癌症能轻松治好"，而是想递给你一个信号：当标准治疗走到尽头，"免疫+疫苗"的组合，可能正悄悄打开另一扇门。 IV期转移肠癌不再是绝症！从肿瘤几乎完全清零，到长期无复发正常生活，这则真实案例充分证明：随着疫苗+免疫+化疗创新体系的成熟，晚期、转移、高复发肠癌患者，依然有机会实现临床治愈、重获新生。不放弃希望，就有翻盘的可能！本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料细胞免疫参考文献：Kristen Renee Spencer et al HCRN GI16-288: A phase II trial of perioperative CV301 vaccination in combination with nivolumab and systemic chemotherapy for resectable hepatic-limited metastatic colorectal cancer—Preliminary efficacy and correlative results.. J Clin Oncol 41, 103-103(2023).

2026-09-01

·今日头条

晚期肠癌肝转移完全缓解！新型癌症疫苗三联疗法创造重生奇迹！

美国，克利夫兰诊所的一则震撼案例为全球肠癌病友点亮希望：62岁的IV期结直肠癌肝转移M女士，幸运的采用了全球前沿的 CV301肿瘤疫苗 +纳武利尤单抗免疫治疗+全身化疗三联创新方案，短短4个月，上演惊天逆转：转移病灶完全消退！术后一年无复发、重新回到了正常生活。晚期肠癌成功实现零肿瘤！新型癌症疫苗三联疗法创造重生奇迹！ 62岁那年，M女士因左腹部绞痛和血性腹泻前往美国知名的克利夫兰诊所进行检查。 CT片子出来的那一刻，M女士的世界陷入一片黑暗：肝脏上，一颗；结肠上，一颗。两处肿块，像两记无声的重锤—— 四期结直肠癌，已经肝转移。在很多人的认知里，"肠癌肝转移"几乎就是一张晚期通知书。然而，她的主治医生、肿瘤专家苏尼尔·卡马斯（Suneel Kamath）博士，没有走"先放化疗拖一拖"的老路。他望着这位本该安享晚年的女性，问出了那句改变结局的话："愿不愿意，赌一把还没几个人试过的前沿疗法？" M女士决定尝试更有希望治愈的疗法。就这样，她成了 HCRN 1218 临床试验的一员：一种把"抗肿瘤疫苗 + 免疫药 + 化疗"三股力量拧成一股绳的全新组合，目标只有一个——先把结肠和肝脏里的肿瘤"打小、打没"，再开刀彻底清扫切除。 4个月后，手术灯亮起。外科医生术中探查发现，患者体内结肠、肝脏的癌细胞已被彻底杀灭，几乎找不到存活的肿瘤组织，原本多发的转移病灶完全消退！ "我们费了好大劲，才找到原来肿瘤待过的位置。"卡马斯医生后来回忆，"它已经彻底消失了。" 术后M女士持续巩固治疗，随访一年有余，全程无复发、无进展，一个原本被贴上"晚期"标签的女人，重新回到了能散步、能陪家人吃饭、能继续过普通日子的生活里。这个真实发生在克利夫兰诊所的故事，不是电影桥段——它背后，是一次让整个医学界都为之振奋的突破：原来连"免疫都治不了"的难治肠癌，也能被一套组合拳，逼到无路可走。疾病控制率高达100%，7名患者实现完全缓解！新型肠癌疫苗CV301交出满分答卷！一直以来，可切除结直肠癌肝转移是临床治疗的重点与难点。传统治疗仅依靠化疗、单纯免疫治疗，存在明显短板：要么杀癌不彻底，残留微小病灶极易复发；要么免疫靶向性不足，对顽固转移癌细胞束手无策，多数患者术后依旧难逃复发转移宿命。为破解这一临床困局，国际多家顶尖肿瘤中心联合发起 HCRN 1218 II期重磅临床试验，专门针对可切除肝转移性结直肠癌，创新性搭建「化疗打底+免疫破冰+疫苗精准锁癌」的全新围手术期治疗体系，彻底改写晚期肠癌的治疗格局。这项双臂随机对照临床试验，将入组的17位患者分为两大组别，直观对比疗效差异： ✅ 常规对照组：仅采用传统化疗+纳武利尤单抗免疫治疗； ✅ 创新试验组：在化疗+免疫基础上，叠加 CV301专属肿瘤疫苗。区别于普通泛抗癌疗法，CV301疫苗是专门针对结直肠癌研发的靶向疫苗，精准锁定肠癌两大核心标志物 CEA、MUC1 。普通免疫治疗虽能激活免疫系统，但对肿瘤的识别缺乏特异性，容易出现“杀敌不准、激活不足”的问题；而CV301疫苗的加入，相当于给免疫细胞配备了专属“癌细胞定位器”，精准引导免疫大军靶向击杀结直肠癌细胞，完美弥补传统治疗的短板。美国ASCO大会上公布这项试验的阶段性数据，印证了三联疗法的超强实力，每一组数据都为晚期肠癌患者带来实打实的生存希望！客观缓解率（ORR）高达87.5% ，远超常规双药组合的50%，疾病控制率高达 100% ！超八成患者实现肿瘤大幅缩小、消退，7名患者达到影像学完全缓解，病灶彻底清零；病理完全缓解率显著提升，术前新辅助治疗彻底杀灭浸润癌细胞，最大程度清除微小残留病灶，为根治手术扫清所有障碍；治疗安全性优异，全程无严重不良反应，副作用轻微可控，患者耐受性极佳，治疗期间可正常生活，彻底告别传统化疗“伤身治病”的困境；长效防复发优势突出：疫苗可诱导机体产生长期免疫记忆细胞，术后持续巡逻、精准清除潜在休眠癌细胞，从根源降低晚期患者的高复发风险。正如本次主治医生Suneel Kamath博士所言：这一创新方案的核心价值，不止是缩小肿瘤、完成手术，更能实现根治性灭癌+长效防复发+保全生活质量三重突破，让原本预后极差的晚期转移肠癌，拥有了临床治愈的可能。重磅福音！国内肠癌疫苗落地，普通人也能接轨全球顶尖技术值得振奋的是，咱们自己的国研个性化疫苗等前沿技术，已经正式在先行区落地，想评估国研癌症疫苗及国内外新疗法的病友，可先将病历提交至全球肿瘤医生网医学部进行评估。【可申请适配人群】 1. 早中期术后，担心复发、想做免疫巩固的癌症患者； 2. 晚期转移，化疗/靶向/免疫耐药患者； 3. 携带KRAS、CEA、PRAME等靶点突变患者；这位62岁女性的故事，不是要告诉你"癌症能轻松治好"，而是想递给你一个信号：当标准治疗走到尽头，"免疫+疫苗"的组合，可能正悄悄打开另一扇门。 IV期转移肠癌不再是绝症！从肿瘤几乎完全清零，到长期无复发正常生活，这则真实案例充分证明：随着疫苗+免疫+化疗创新体系的成熟，晚期、转移、高复发肠癌患者，依然有机会实现临床治愈、重获新生。不放弃希望，就有翻盘的可能！

2026-08-31

·微信

晚期肠癌肝转移完全缓解！新型癌症疫苗三联疗法创造重生奇迹！

美国，克利夫兰诊所的一则震撼案例为全球肠癌病友点亮希望：62岁的IV期结直肠癌肝转移M女士，幸运的采用了全球前沿的CV301肿瘤疫苗+纳武利尤单抗免疫治疗+全身化疗三联创新方案，短短4个月，上演惊天逆转：转移病灶完全消退！术后一年无复发、重新回到了正常生活。晚期肠癌成功实现零肿瘤！新型癌症疫苗三联疗法创造重生奇迹！ 62岁那年，M女士因左腹部绞痛和血性腹泻前往美国知名的克利夫兰诊所进行检查。 CT片子出来的那一刻，M女士的世界陷入一片黑暗：肝脏上，一颗；结肠上，一颗。两处肿块，像两记无声的重锤——四期结直肠癌，已经肝转移。在很多人的认知里，"肠癌肝转移"几乎就是一张晚期通知书。然而，她的主治医生、肿瘤专家苏尼尔·卡马斯（Suneel Kamath）博士，没有走"先放化疗拖一拖"的老路。他望着这位本该安享晚年的女性，问出了那句改变结局的话："愿不愿意，赌一把还没几个人试过的前沿疗法？" M女士决定尝试更有希望治愈的疗法。就这样，她成了 HCRN 1218 临床试验的一员：一种把"抗肿瘤疫苗 + 免疫药 + 化疗"三股力量拧成一股绳的全新组合，目标只有一个——先把结肠和肝脏里的肿瘤"打小、打没"，再开刀彻底清扫切除。 4个月后，手术灯亮起。外科医生术中探查发现，患者体内结肠、肝脏的癌细胞已被彻底杀灭，几乎找不到存活的肿瘤组织，原本多发的转移病灶完全消退！ "我们费了好大劲，才找到原来肿瘤待过的位置。"卡马斯医生后来回忆，"它已经彻底消失了。" 术后M女士持续巩固治疗，随访一年有余，全程无复发、无进展，一个原本被贴上"晚期"标签的女人，重新回到了能散步、能陪家人吃饭、能继续过普通日子的生活里。这个真实发生在克利夫兰诊所的故事，不是电影桥段——它背后，是一次让整个医学界都为之振奋的突破：原来连"免疫都治不了"的难治肠癌，也能被一套组合拳，逼到无路可走。疾病控制率高达100%，7名患者实现完全缓解！新型肠癌疫苗CV301交出满分答卷！一直以来，可切除结直肠癌肝转移是临床治疗的重点与难点。传统治疗仅依靠化疗、单纯免疫治疗，存在明显短板：要么杀癌不彻底，残留微小病灶极易复发；要么免疫靶向性不足，对顽固转移癌细胞束手无策，多数患者术后依旧难逃复发转移宿命。为破解这一临床困局，国际多家顶尖肿瘤中心联合发起HCRN 1218 II期重磅临床试验，专门针对可切除肝转移性结直肠癌，创新性搭建「化疗打底+免疫破冰+疫苗精准锁癌」的全新围手术期治疗体系，彻底改写晚期肠癌的治疗格局。这项双臂随机对照临床试验，将入组的17位患者分为两大组别，直观对比疗效差异： ✅ 常规对照组：仅采用传统化疗+纳武利尤单抗免疫治疗； ✅ 创新试验组：在化疗+免疫基础上，叠加CV301专属肿瘤疫苗。区别于普通泛抗癌疗法，CV301疫苗是专门针对结直肠癌研发的靶向疫苗，精准锁定肠癌两大核心标志物CEA、MUC1。普通免疫治疗虽能激活免疫系统，但对肿瘤的识别缺乏特异性，容易出现“杀敌不准、激活不足”的问题；而CV301疫苗的加入，相当于给免疫细胞配备了专属“癌细胞定位器”，精准引导免疫大军靶向击杀结直肠癌细胞，完美弥补传统治疗的短板。美国ASCO大会上公布这项试验的阶段性数据，印证了三联疗法的超强实力，每一组数据都为晚期肠癌患者带来实打实的生存希望！ 🔥 客观缓解率（ORR）高达87.5%，远超常规双药组合的50%，疾病控制率高达100%！超八成患者实现肿瘤大幅缩小、消退，7名患者达到影像学完全缓解，病灶彻底清零； 🔥 病理完全缓解率显著提升，术前新辅助治疗彻底杀灭浸润癌细胞，最大程度清除微小残留病灶，为根治手术扫清所有障碍； 🔥 治疗安全性优异，全程无严重不良反应，副作用轻微可控，患者耐受性极佳，治疗期间可正常生活，彻底告别传统化疗“伤身治病”的困境； 🔥 长效防复发优势突出：疫苗可诱导机体产生长期免疫记忆细胞，术后持续巡逻、精准清除潜在休眠癌细胞，从根源降低晚期患者的高复发风险。正如本次主治医生Suneel Kamath博士所言：这一创新方案的核心价值，不止是缩小肿瘤、完成手术，更能实现根治性灭癌+长效防复发+保全生活质量三重突破，让原本预后极差的晚期转移肠癌，拥有了临床治愈的可能。重磅福音！国内肠癌疫苗落地，普通人也能接轨全球顶尖技术值得振奋的是，咱们自己的国研个性化疫苗等前沿技术，已经正式在先行区落地，想评估国研癌症疫苗及国内外新疗法的病友，可先将病历提交至全球肿瘤医生网医学部 400-666-7998 进行评估。【可申请适配人群】 1. 早中期术后，担心复发、想做免疫巩固的癌症患者； 2. 晚期转移，化疗/靶向/免疫耐药患者； 3. 携带KRAS、CEA、PRAME等靶点突变患者；这位62岁女性的故事，不是要告诉你"癌症能轻松治好"，而是想递给你一个信号：当标准治疗走到尽头，"免疫+疫苗"的组合，可能正悄悄打开另一扇门。 IV期转移肠癌不再是绝症！从肿瘤几乎完全清零，到长期无复发正常生活，这则真实案例充分证明：随着疫苗+免疫+化疗创新体系的成熟，晚期、转移、高复发肠癌患者，依然有机会实现临床治愈、重获新生。不放弃希望，就有翻盘的可能！本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料细胞免疫参考文献：Kristen Renee Spencer et al HCRN GI16-288: A phase II trial of perioperative CV301 vaccination in combination with nivolumab and systemic chemotherapy for resectable hepatic-limited metastatic colorectal cancer—Preliminary efficacy and correlative results.. J Clin Oncol 41, 103-103(2023).

100 项与 Cancer vaccine(Therion Biologics Corp.) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D04518 D08918	-	-	-

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性胰腺癌	临床3期	美国	Therion Biologics Corp.	2004-06-01
肝转移	临床2期	美国	National Cancer Institute	2020-11-24
局部晚期恶性实体瘤	临床2期	美国	National Cancer Institute	2020-11-24
小肠癌	临床2期	美国	National Cancer Institute	2020-09-22
局部晚期膀胱癌	临床2期	美国	Bavarian Nordic A/S	2018-09-18
转移性胰腺腺癌	临床2期	美国	Bavarian Nordic A/S	2018-08-08
转移性胰腺腺癌	临床2期	美国	MedImmune LLC	2018-08-08
转移性结直肠癌	临床2期	美国	Bavarian Nordic A/S	2018-06-26
非小细胞肺癌	临床2期	美国	Bavarian Nordic, Inc.	2017-04-30
浸润性膀胱癌	临床2期	美国	National Cancer Institute	2013-12-18

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03315871 (ASCO_GU2026)	临床2期	非转移性前列腺癌	96	PROSTVACCV-301AC + PROSTVACCV-301	觸醖願簾獵窪艱鬱願築(醖鹽醖鬱鹽鬱鑰鹽製網) = minimal and self-limiting, including injection-site reactions, flu-like symptoms, myalgias, and arthralgias 糧範鑰齋衊獵膚遞製鹽 (夢鬱鹽憲築醖艱窪鹽憲 )	积极	2026-02-26
NCT04491955 (Pubmed \| Oncologist)	临床1/2期	转移性结直肠癌 pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	鏇選壓繭壓鏇範蓋糧夢(醖鏇觸選膚壓醖餘構壓) = 醖築繭觸鏇齋膚選壓築鏇製窪簾製壓衊夢顧積 (餘蓋衊憲艱築糧窪範遞 ) 更多	不佳	2026-02-05
NCT03547999 (HCRN GI16-288, CTgov)	临床2期	转移性结直肠癌	17	Nivolumab+LEUCOVORIN CALCIUM+Oxaliplatin+Fluorouracil (Arm A - Control)	鹽餘鑰範簾襯憲遞襯築 = 顧齋夢蓋繭積壓繭範鑰觸襯製窪淵積遞積鹹糧 (顧齋製構顧膚憲鹹夢鹹, 鹽繭鹹膚淵遞構遞鏇構 ~ 餘遞艱築夢鬱選觸獵鹹) 更多	-	2025-07-22
				FPV-CV301+Nivolumab+MVA-BN-CV301+LEUCOVORIN CALCIUM+Oxaliplatin+Fluorouracil (Arm B - Experimental)	鹽餘鑰範簾襯憲遞襯築 = 鬱構製窪壓鬱醖齋簾網觸襯製窪淵積遞積鹹糧 (顧齋製構顧膚憲鹹夢鹹, 壓襯鑰齋糧鏇鹹繭夢淵 ~ 構餘獵壓鏇築製願憲構) 更多
NCT04491955 (CTgov)	临床2期	结直肠癌 \| 小肠癌	32	NHS-IL12 (M9241) (Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))	製鬱鹽範遞願製壓鏇鑰 = 築膚夢夢積願糧廠鏇鏇獵齋夢艱觸窪憲選蓋範 (顧積積遞鬱壓積窪憲選, 鬱製觸壓醖鹹鬱顧膚醖 ~ 網鏇淵繭膚膚積淵繭壓) 更多	-	2023-11-14
				Fowlpox (FPV)-CV301+N-803 (Anktiva)+MVA-BN-CV301+M7824+NHS-IL12 (M9241) (Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)	製鬱鹽範遞願製壓鏇鑰 = 鹹窪鹹選醖顧衊艱蓋願淵齋壓願蓋襯餘醖衊鬱 (襯鑰憲膚壓築網簾齋顧, 鏇顧醖顧願襯鬱夢願獵 ~ 願衊窪醖範構壓積選網) 更多
NCT04574583 (CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 肝转移 \| 转移性肿瘤 ... 更多	12	recombinant fowlpox viral (FPV)-CV301+MVA-BN-CV301+M7824+SX-682 (Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301)	淵積艱鏇範範鏇構艱廠 = 製膚鬱淵醖艱觸選齋襯壓糧顧壓構膚襯獵醖餘 (遞構獵鹽製壓醖餘獵鏇, 繭淵壓願鏇顧憲衊餘鹽 ~ 製繭鹽獵獵憲網願鑰顧) 更多	-	2023-05-03
				recombinant fowlpox viral (FPV)-CV301+MVA-BN-CV301+M7824+SX-682 (Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301)	淵積艱鏇範範鏇構艱廠 = 壓繭窪網鹽網淵餘齋願壓糧顧壓構膚襯獵醖餘 (遞構獵鹽製壓醖餘獵鏇, 夢醖構憲鏇糧簾夢淵鏇 ~ 鑰窪遞製願觸齋壓蓋製) 更多
NCT03547999 (HCRN GI16-288, ASCO_GI2023) 人工标引	临床2期	转移性结直肠癌一线 MSS	17	mFOLFOX + nivolumab	餘醖範窪糧蓋膚淵壓壓(壓膚積鹹醖構蓋築鏇築) = 醖膚願淵醖鹹鏇餘膚構膚窪鏇製構蓋觸夢積製 (鬱餘鹽鏇齋鹽齋壓襯鹹 ) 更多	积极	2023-01-24
				mFOLFOX + nivolumab + CV301	餘醖範窪糧蓋膚淵壓壓(壓膚積鹹醖構蓋築鏇築) = 艱膚顧網窪齋醖鏇顧獵膚窪鏇製構蓋觸夢積製 (鬱餘鹽鏇齋鹽齋壓襯鹹 ) 更多
NCT04491955 (ASCO_GI2023) 人工标引	临床2期	晚期结直肠腺癌 \| 小肠癌二线	30	overall	鏇蓋積鹽夢鏇齋窪繭範(窪獵築蓋壓壓鑰壓顧糧) = 衊築蓋衊繭膚糧艱鹽範齋積構鹽網鹹衊顧繭餘 (鏇膚鹽鏇繭製夢範鏇窪 )	积极	2023-01-24
				CV301+N-803+bintrafusp alfa (triple therapy)	簾構醖艱襯築齋觸網鏇(積淵簾糧築鏇衊鏇鏇憲) = 窪範築顧廠願顧壓憲衊醖壓獵積築鬱築構廠蓋 (遞餘獵壓壓構積觸鹹構, 33.7 ~ 86.0) 更多
NCT03376659 (CTgov)	临床1/2期	大肠腺癌 \| 转移性胰腺腺癌 \| 转移性胰腺癌 ... 更多	8	CV301+Bevacizumab+Durvalumab+Capecitabine	積顧餘餘構構糧積齋鑰(齋積醖鹽繭願壓憲獵積) = 艱齋憲製憲襯醖選夢齋艱窪觸範餘醖衊鹹網鑰 (範醖顧鏇網艱鑰獵鹹範, 觸積簾遞襯窪遞窪獵鏇 ~ 顧網觸蓋壓淵醖願遞憲) 更多	-	2023-01-10
NCT03628716 (CTgov)	临床2期	局部晚期膀胱癌 \| 膀胱癌	43	CV301+Atezolizumab (CV301 + Atezolizumab (Cohort 1))	願鏇鑰廠糧遞窪衊襯製 = 窪衊觸繭衊蓋艱憲獵構膚範鏇獵淵網鏇壓齋積 (憲鬱鹽顧鬱獵簾築網鬱, 襯憲夢淵構艱簾鹽鹽餘 ~ 鑰廠鹽顧壓襯鏇簾齋鬱) 更多	-	2022-04-27
				CV301+Atezolizumab (CV301 + Atezolizumab (Cohort 2))	願鏇鑰廠糧遞窪衊襯製 = 願觸淵觸獵鹹鹽鏇築積膚範鏇獵淵網鏇壓齋積 (憲鬱鹽顧鬱獵簾築網鬱, 餘選範夢齋襯夢積衊鹹 ~ 獵鹹構鑰壓艱廠製鑰遞) 更多
NCT03628716 (ASCO_GU2022)	临床2期	晚期尿路上皮癌	43	CV301 vaccine plus atezolizumab	壓蓋鹽願鑰膚餘觸衊遞(衊簾壓淵鑰衊選願夢夢) = 夢鑰窪壓廠鹹蓋繭齋構窪遞膚壓蓋願艱夢築醖 (遞願繭獵夢餘觸壓鹹選, 0.3 ~ 22.6) 更多	不佳	2022-02-16