本月，我们将与Maia和Manju讨论针对II期或III期结直肠癌（CRC）患者的试验。

为什么早期的CRC患者开始寻找试验很重要？

曼珠。 好问题!该领域可能有新的发展，正在通过临床试验进行测试，早期患者可能只有通过试验才能获得，例如治疗直肠癌的新方法，或者是寻找临床效用的试验。 ctDNA. In many of these cases, early-stage patients would likely be randomized to get Standard of Care (SOC) treatments for their condition or that plus the experimental intervention. Early-stage CRC clinical trials allow patients as a group to have more treatment options. Maia, did I cover the important points?

马亚。 Absolutely. Stages II and III patients receive surgery with curative intent, so it’s unlikely most patients and even doctors will think about clinical trials in those cases. However, as you said, a clinical trial may provide access to a cutting-edge technology (without compromising standard of care, of course), for example: a new surgical approach; a new way to dose chemotherapy, to maximize results while minimizing side effects; a non-invasive monitoring tool, like ctDNA; an immunotherapy to prevent recurrence.

你们都对第二阶段和第三阶段社区应该知道的哪些试验感到兴奋？

马亚。 我想强调的是旨在通过征集免疫系统来防止复发的临床试验。我们强大的免疫系统不断地工作，以识别和消除那些有损坏的DNA的细胞，因此，有可能成为癌症。从这个意义上说，癌症是免疫功能失调的一种表现形式。手术、化疗、靶向治疗和放疗针对的是癌症本身，而免疫疗法是一类通过帮助免疫系统识别和攻击癌细胞而发挥作用的治疗方法，因为它应该这样做。通过这样做，免疫疗法正在为许多癌症提供持久的反应。 

对于CRC患者来说，有一种免疫疗法正在对早期患者进行临床试验：疫苗。

iNeST RO7198457（Autogene cevumeran）是一种基于mRNA的个性化癌症疫苗，在12个月内静脉注射给II期（高风险）和III期CRC患者，这些患者在切除后ctDNA检测呈阳性。在 本审判接受疫苗的病人的结果将与接受标准护理（"观察性等待 "方法）的病人的结果进行比较。

Even if the vaccine is a novel agent, it is not totally unknown by now:  A 先前的审判 used this vaccine combined with other immunotherapy for treatment of stage IV patients. Even if the clinical response was low when trying to treat patients with active cancer, the researchers determined that the vaccine does generate tumor-specific immune responses, and it is safe. The vaccine may have a role when used to prevent recurrence, with no active disease, and this trial looks forward to answering that question and, hopefully, helping many patients to keep no evidence of disease (NED).

Ad5.F35-hGCC-PADRE is another vaccine being investigated in a 临床试验 for many cancers, and that recruits stages I, II, III (and even stage IV with NED) CRC patients. This Guanylyl Cyclase C Vaccine is for prevention of recurrence, in patients treated with curative intent, who have NED following front-line therapy with surgery, radiation therapy, and/or chemotherapy. Thomas Jefferson University (Philadelphia, PA) has been researching and conducting other trials with this vaccine for years, so there is literature about its safety and efficacy.

而且有更多针对II期和III期患者的临床试验，可能有助于避免复发，并将通过提供彻底的随访使他们受益。

At risk of sounding like a broken record: There are clinical trials for every step in this journey, for those who think a clinical trial might be helpful. Clinical trials are not the last resource, nor do they always use completely unknown agents. Just keep on the loop: You or a loved one may be helped by a clinical trial.

曼珠。 I have been watching the early-stage CRC ctDNA space, and two trials are very interesting to me. There are many new trials coming up, so this is an exciting area to follow.

And there are more clinical trials for stages II and III patients that may help to avoid recurrence and will benefit them by providing thorough follow up watching the early-stage CRC ctDNA space, and two trials are very interesting to me. There are many new trials coming up, so this is an exciting area to follow.

The COBRA Trial for Stage II Colon Cancer (PI: Dr. Morris) is for early stage (IIa) colon cancer patients after curative intent surgery, for whom chemotherapy is not otherwise recommended. This trial has two arms: In arm one, patients receive standard follow-up as they would otherwise. They will have regular surveillance checkups including blood collection for ctDNA testing, but they won’t get any additional treatments.

In arm two, based on their ctDNA test when they enroll in the study, if ctDNA positive, their doctor will start them on the course of chemotherapy that is best for them. If their ctDNA test is negative, then they will get regular checkups including ctDNA tests for a period of three years while they are on the study.

And there are more clinical trials for stages II and III patients that may help to avoid recurrence and will benefit them by providing thorough follow up watching the early-stage CRC CtDNA space, and two trials are very interesting to me. There are many new trials coming that is best for them. If their CtDNA test is negative, then they will get regular checkups including ctDNA tests for a period of three years while they are on the study.

The Stand Up To Cancer ctDNA Trial (PI: Dr. Parikh) is for stage III colon cancer patients who have recently completed all their treatments. They get tested for ctDNA and if positive, they are randomized to 1) active surveillance, or 2)  be eligible based on their tumor characteristics, to receive either the next line of chemotherapy (福尔费里), or targeted therapy (if BRAF mutated or Her2 amplified), or immunotherapy if MSI-H.那些ctDNA检测为阴性的患者将接受推荐给III期患者的积极监测。该试验的目的是弄清楚ctDNA阳性患者在积极监测与更多治疗之间是否存在癌症复发和健康方面的差异，以及更多治疗如何影响ctDNA水平。该试验目前在马萨诸塞州总医院、纪念斯隆-凯特琳癌症中心、康奈尔、丹娜-法伯癌症研究所和约翰-霍普金斯开放。

These trials are very interesting to me because they can tell us whether detecting recurrence early via ctDNA positivity and treating early with chemotherapy (before things show up on a scan) affects the outcomes for patients with stages II and III colon cancer. Such trials are critical to assess the clinical utility of ctDNA testing.

要了解更多关于临床试验的信息，请务必查看我们的 资源 and download the Fight CRC Clinical Trial brochure.

搏击中心与病人社区携手合作，通过解决这些问题来发现改善和延长生命的新方法。为使临床试验惠及其目标人群，必须增加参与者的种族和民族多样性。

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每月一次，Maia和Manju将花时间为我们的社区解读重要的研究试验、技巧和建议。请务必订阅 报名 with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

你也可以关注Maia (@sassycell) 和 Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

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