盐酸伊立替康(Irinotecan Hydrochloride) - 药物靶点：Top I_在研适应症：儿童恶性实体瘤，肠肿瘤，结肠癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ASC-201 - Ascelia Pharma、IHT、irinotecan

+ [39]

靶点

Top I

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [7]

在研适应症

儿童恶性实体瘤肠肿瘤结肠癌+ [36]

非在研适应症

腺癌食管腺癌大肠腺癌+ [61]

原研机构

Yakult Honsha Co., Ltd.

在研机构

Daiichi Sankyo Co., Ltd.

Eli Lilly & Co.

Yakult Honsha Co., Ltd.

+ [13]

非在研机构

Servier Deutschland GmbH

Bristol Myers Squibb Co.

Pharmacia Corp.

+ [18]

权益机构

Hanmi Pharmaceutical Co., Ltd.Athenex Pharmaceuticals Co. Ltd.

Daiichi Sankyo Co., Ltd.

+ [5]

最高研发阶段批准上市

首次获批日期

日本 (1994-01-19),

非小细胞肺癌卵巢癌胰腺癌+ [3]

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、优先审评 (中国)

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结构/序列

分子式C33H45ClN4O9

InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N

CAS号136572-09-3

关联

1,715

项与盐酸伊立替康相关的临床试验

NCT07363408

/ Not yet recruiting临床1期IIT

A Phase I Clinical Trial of Ivonescimab and ADG126, Alone, and in Combination With 5-FU/LV or FOLFIRI in MSS Advanced/Metastatic Colorectal Cancer

This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ivonescimab, leucovorin, and fluorouracil, or in combination with ivonescimab and leucovorin, fluorouracil, and irinotecan (FOLFIRI regimen) in treating patients with microsatellite stable (MSS) colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ivonescimab and ADG126, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Leucovorin calcium is a type of drug called a folic acid analog, which means it is similar to the vitamin folic acid. It is used in combination with certain chemotherapy drugs to enhance their ability to kill tumor cells or to lessen their harmful side effects. Fluorouracil is a type of chemotherapy called an antimetabolite, which is a drug that mimics a natural chemical and prevents its use in cells. It interferes with the production of a key component of deoxyribonucleic acid (DNA), which prevents the DNA from copying itself. This causes tumor cells and other rapidly dividing cells to die. Fluorouracil also gets incorporated into ribonucleic acid (RNA) and DNA, disrupting critical cell functions. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving ADG126 with ivonescimab, with or without leucovorin and fluorouracil or FOLFIRI regimen, may be safe in treating patients with MSS advanced/metastatic colorectal cancer.

开始日期2026-07-21

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07271355

/ Not yet recruiting临床3期IIT

Investigation of Mitomycin C PIPAC - FOLFIRI Combination for Unresectable Appendiceal or Colorectal Peritoneal Metastases Treatment (IMPACT): A Multicenter, Randomized, Open-Label, Phase 3 Trial

This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride [FOLFIRI regimen] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases). PIPAC is a new therapeutic approach that is minimally invasive, does not require surgery (laparotomy), and can be frequently repeated. Chemotherapy is delivered as a pressurized mist directly inside the abdominal cavity (peritoneum) during a minimally invasive surgery called a laparoscopy. The pressure helps the chemotherapy absorb into the cancer tissue and spread more evenly. Mitomycin is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their deoxyribonucleic acid (DNA). Standard chemotherapy drugs, such as those in the FOLFIRI regimen, are given via infusion into a vein (intravenously), and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Another standard intravenous drug, bevacizumab, is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving mitomycin via PIPAC in combination with the standard FOLFIRI regimen, with or without bevacizumab, may work better than standard FOLFIRI plus bevacizumab alone in treating patients with unresectable appendix or colorectal cancer with peritoneal metastases.

开始日期2026-07-01

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07415031

/ Not yet recruiting临床2期

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

开始日期2026-05-16

申办/合作机构

Mirati Therapeutics, Inc.

100 项与盐酸伊立替康相关的临床结果

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100 项与盐酸伊立替康相关的转化医学

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100 项与盐酸伊立替康相关的专利（医药）

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8,445

项与盐酸伊立替康相关的文献（医药）

2026-06-01·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Combined antitumor efficacy of a new tanshinone IIA analog and irinotecan with alleviating gastrointestinal side effect

Article

作者: Wang, Junfeng ; Li, Hao ; Kai, Guoyin ; Zhang, Shuai ; Xu, Huan ; Sun, Chengtao ; Luo, Jiamin ; Mang, Zhiguo

1,6,6-Trimethyl-2-((4-methylpiperazin-1-yl)methyl)phenanthrol[1,2-b]furan-7,10,11(6H)-trione (TA401), a newly synthesized tanshinone IIA analog, was developed to enhance the anti-tumor effect of CPT-11 in combined therapy and alleviate its gastrointestinal side effect. The combined cytotoxicity on HT29 and HCT116 colorectal cancer cells induced by TA401 and CPT-11 was comprehensively evaluated in vitro. The classical apoptosis pathway, including Bax, BCL-2, caspase 3, the phosphorylation level of ERK and AKT, was also examined to illustrate molecular mechanisms of the synergistic apoptosis both in vitro and in vivo. Synergistic suppression of colorectal cancer cell proliferation by TA401 and CPT-11 was observed at a fixed ratio (TA401:CPT-11 at 1:20). The apoptosis induced by combined treatment was triggered by activation of classical apoptotic pathway and decreased expression of TOP I, which was further confirmed in vivo. In addition, diarrheic side effect of CPT-11 was reduced by TA401 in the combined treatment. TA401 effectively promoted the anti-tumor effects of CPT-11 with alleviated side effects, which may be developed as a potential candidate for the combined therapy with CPT-11 against colorectal cancer.

2026-06-01·ACTA HISTOCHEMICA

Anticancer drug-treated fibroblasts modulate colon cancer cell behavior through lysophosphatidic acid (LPA) receptor-mediated signaling

Article

作者: Yamamoto, Mao ; Yashiro, Narumi ; Shimomura, Nanami ; Kusumoto, Yuka ; Tamura, Moemi ; Tsujiuchi, Toshifumi ; Nagano, Shion

Lysophosphatidic acid (LPA) receptor-mediated signaling contributes to the pathogenesis of cancer. The tumor microenvironment (TME), composed of cancer cells and surrounding stromal cells, plays a key role in promoting malignant traits, including resistance to anticancer drugs. In this study, we investigated the roles of LPA receptor-1 (LPA₁) and LPA₂ in colon cancer DLD-1 cell functions modulated by 3T3 fibroblasts chronically exposed to chemotherapy. 3T3 cells were treated long-term with fluorouracil (5-FU), irinotecan (CPT-11), or cisplatin (CDDP) to generate 3T3-5FU, 3T3-CPT11, and 3T3-CDDP cells, respectively. Co-culture with anticancer drug-treated 3T3 cells altered LPA receptor expression in DLD-1 cells, characterized by reduced LPAR1 and elevated LPAR2 levels, compared with co-culture with untreated fibroblasts (n = 3 independent experiments). Under these conditions, LPA stimulation enhanced DLD-1 cell proliferation and motility. Pharmacological modulation of LPA signaling further supported receptor-specific effects: the LPA₁ antagonist AM966 and the LPA₂ agonist GRI-977143 promoted DLD-1 cell growth, while AM966 suppressed and GRI-977143 enhanced cell motility in co-culture with drug-treated fibroblasts. These findings suggest that chemotherapy-conditioned fibroblasts reshape LPA receptor-dependent signaling in colon cancer cells, suggesting potential therapeutic relevance of distinct roles for LPA₁ and LPA₂ within the drug-modified TME.

2026-05-01·JOURNAL OF ETHNOPHARMACOLOGY

Xiao-Chaihu-Tang preserves intestinal barrier and ameliorates irinotecan-evoked delayed diarrhea by anchoring endogenous tryptophol to modulate inflammation and oxidation dependent on AhR-UGT1A1-microbiota axis

Article

作者: Zhang, Xiaohang ; Yang, Peishan ; Chen, Qinhua ; Wang, Li ; Cao, Yuanyuan ; Zhang, Zhenyi ; Yang, Guangyi ; Xu, Min ; Yang, Yang ; Zeng, Min ; Yan, Hui ; Zhao, Qiulong ; Mao, Yaqing

ETHNOPHARMACOLOGICAL RELEVANCE:

Xiao-Chaihu-Tang (XCHT), a well-known traditional formula, is commonly used to treat various types of diarrhea. It also exhibits promising efficacy against chemotherapy irinotecan (CPT-11)-induced delayed diarrhea (DD). However, its underlying mechanisms, specifically concerning endogenous metabolites, key pathways, and functional gut bacteria at the species level, remain unclear, severely restricting its clinical application.

AIM OF THE STUDY:

This study aimed to elucidate the biomarkers, pathways, and functional bacteria involved in XCHT's alleviating CPT-11-evoked DD using multi-omics approaches, antagonists, and fecal microbiota transplantation (FMT).

MATERIALS AND METHODS:

First, the ingredients of XCHT and absorbed compounds in rat plasma were identified using liquid chromatography-mass spectrometry (LC-MS). Next, the therapeutic effects of XCHT were assessed by monitoring perianal status, body weight, disease activity index, food and water intake, and histopathological changes in the colon (hematoxylin and eosin, alcian blue-periodic acid-schiff staining). The underlying mechanisms were studied using metabolomics and network pharmacology, which highlighted the role of endogenous biomarkers and associated pathways. Tryptophol was identified as a key correlate, and its efficacy was further validated in rat and Caco-2 models using antagonists of potential targets (AhR and UGT1A1). The levels of inflammatory cytokines, and oxidative stress markers, intestinal barrier proteins, and mucins were detected by enzyme-linked immunosorbent assay (ELISA), Western blotting, and immunofluorescence. Furthermore, functional gut bacteria were identified using metagenomic sequencing and validated using FMT, while gut leakage was detected using fluorescence in situ hybridization (FISH). Finally, the interactions between tryptophol with targets of AhR and UGT1A1 were examined using molecular docking, molecular dynamics, and surface plasmon resonance.

RESULTS:

LC-MS analysis identified 43 phytochemicals in XCHT and 17 compounds absorbed in plasma. XCHT, similar to tryptophol, attenuated DD by improving perianal status, disease activity index, and colon pathology, while increasing body weight, food intake, and water intake. Metabolomics analysis revealed 33 potential endogenous biomarkers, including PGB₃, LysoPA, and so on. Integrated with network pharmacology, the results indicated that the therapeutic effect of XCHT involved the regulation of tryptophan metabolism, arachidonic acid metabolism, inflammation, and oxidative stress. Tryptophol, which exhibited a strong correlation with efficacy indices, reduced inflammation and oxidation in vivo/vitro, and enhanced intestinal barrier protein and mucin expression in an AhR-UGT1A1-dependent manner. Furthermore, metagenomic sequencing and FISH demonstrated that both XCHT and tryptophol normalized the abundance of 10 gut bacterial species (for example, Lactobacillaceae bacterium, Massiliimalia timonensis, and Limosilactobacillus reuteri) and inhibited bacterial invasion. Molecular interaction studies confirmed the strong binding between tryptophol with AhR and UGT1A1.

CONCLUSION:

This study demonstrates that XCHT preserves intestinal barrier integrity in rats and alleviates CPT-11-induced DD. This protective effect is mediated by modulating inflammation and oxidative stress via the tryptophol- AhR-UGT1A1-microbiota axis, providing a novel paradigm for mechanistic studies on toxicity reduction in clinical chemotherapy drugs.

2,034

项与盐酸伊立替康相关的新闻（医药）

2026-03-11

·癌度

突破性ADC药物XNW27011启动III期临床！为CLDN18.2阳性胃癌患者带来新希望！

临床试验病友交流群（点击）在胃癌治疗领域，尤其是对于经过多线治疗失败的CLDN18.2阳性胃癌患者，下面为大家介绍一款免费的临床试验新药！新一代靶向CLDN18.2的抗体偶联药物（ADC）XNW27011，凭借其在I/II期临床研究中的优异数据，于2025年5月被CDE拟纳入突破性治疗品种。该药物的首个III期临床试验（CTR20252730）正在全国多中心招募患者。一、数据亮眼：后线患者的强劲选择在刚刚过去的2025年ASCO年会上，XNW27011公布了其针对CLDN18.2阳性胃/胃食管结合部癌（GC/GEJC）的I/II期扩展队列最新结果，数据十分惊艳。这是一项针对既往中位治疗线数达到2线的晚期患者的研究。数据显示在84例扩展队列的胃/胃食管结合部癌患者中，75例可评估疗效的患者取得了高达46.7%的最佳客观缓解率（BOR）和88.0%的疾病控制率（DCR）。尤其在高剂量组（3.6 mg/kg）中，最佳客观缓解率（BOR）达到了66.7%，这为那些经过标准治疗失败的难治性患者提供了强有力的治疗选择。此外，研究证实其良好的安全性特征，最常见的治疗相关不良事件主要为恶心、呕吐及血液学相关事件，整体可控。基于I/II期临床试验所展现出来的巨大潜力，XNW27011对比研究者选择的治疗方案的III期研究已全面启动。二、招募信息与入选要求目前“XNW27011在局部晚期或转移性胃/胃食管结合部腺癌患者中的III期研究” 正在火热招募中。试验登记号：CTR20252730 主要入选标准：基本条件：年龄≥18周岁；ECOG体力评分0-1分。病理要求：经组织学或细胞学确认的不可切除的局部晚期或转移性胃/胃食管结合部腺癌。 CLDN18.2阳性（要求IHC染色强度2+，且肿瘤细胞比例≥20%）。 HER2状态：HER2阴性。治疗线数：既往接受过至少2种系统性治疗（需包含氟尿嘧啶类和铂类）并发生疾病进展，既往治疗线数不超过4线。治疗方案：实验组： XNW27011（靶向CLDN18.2的新一代ADC药物）对照组：研究者选择的治疗方案（阿帕替尼/紫杉醇/伊立替康）特别提醒（排除要点）：如果您既往使用过CLDN18.2 ADC或CAR-T治疗，不能参加这个临床试验。如果您既往使用过其他CLDN18.2单抗/双抗，重新穿刺检测仍为阳性的患者，仍有机会纳入。如果您想了解更多详情，或评估是否符合入组条件，请微信扫描下面的二维码联系癌度咨询。欢迎微信扫描下面的二维码报名咨询！

2026-03-11

·国际干细胞与免疫细胞研究

全球首例！肠道菌群三药联合助患者达病理完全缓解，病灶全缩小

点击蓝字关注我们结直肠癌（CRC）是全球第三大常见恶性肿瘤，仅次于乳腺癌与肺癌。免疫检查点抑制剂（ICI）在晚期或转移性结直肠癌（mCRC）治疗中展现出巨大潜力，尤其对有错配修复缺陷（dMMR）和微卫星不稳定性高（MSI-H）的患者疗效显著；但对于错配修复功能良好（pMMR）、微卫星稳定（MSS）或微卫星不稳定性低（MSI-L）的患者，ICI响应率极低。因此，为这类患者寻找新的治疗策略迫在眉睫。多项研究提示，肠道菌群调节或可改善CRC患者对ICI的耐药问题。在此基础上，我国研究人员取得突破性进展——《Cureus》期刊报道了全球首例“替雷利珠单抗+贝伐珠单抗+FMT胶囊”联合治疗IV期pMMR/MSS转移性结直肠癌的病例，该方案成功将肿瘤缩小至可根治性手术范围，最终实现病理完全缓解（pCR）！全球首例！粪菌移植联合替雷利珠单抗+贝伐珠单抗三管齐下，助晚期结直肠癌患者病灶全缩小，肿瘤标志物骤降该患者是一位57岁中国男性，确诊为升结肠错配修复充分（pMMR）晚期转移性结直肠癌（mCRC），伴继发性肝脏恶性肿瘤，近半个月来反复出现腹痛、大便性状异常等症状。基因检测显示KRAS/NRAS/BRAF均为野生型，临床分期为cT4bN2M1b Ⅳb期。患者先后接受三次治疗：首次入组Ⅱ期临床试验，采用CPGJ602+mFOLFOX6（奥沙利铂+氟尿嘧啶+亚叶酸钙）方案，疗效不佳；随后改为贝伐单抗联合FOLFOXIRI（奥沙利铂+伊立替康+亚叶酸钙）方案，完成3个周期后CT评估达部分缓解（PR），但因高强度化疗引发消化道反应、骨髓抑制等严重副作用，患者拒绝继续该方案，且病情暂不适合根治性手术，最终接受第三次治疗——口服肠道菌群胶囊联合替雷利珠单抗+贝伐单抗。治疗后疗效显著，结果显示如下： 1、肿瘤标志物大幅下降：癌胚抗原（CEA）从入院时的30.1μg/L骤降至4.3μg/L，CA19-9从62.64kU/L降至23.97kU/L。 2、病灶全面缩小并达PR：相较于第二次治疗后“结肠及淋巴结病灶缩小、肝转移灶无变化”的情况，此次所有病灶均明显缩小——CT显示结肠肿瘤从3.7cm×3.1cm缩小至2.1cm×1.7cm，腹膜后淋巴结转移灶从5.2cm×4.3cm缩小至2.3cm×1.4cm，肝脏肿瘤从3.9cm×3.2cm缩小至2.9cm×2.3cm（详见下图）。肿瘤缩小至可手术切除的程度。术后，患者获得病理完全缓解（pCR）。 ▼该患者第二次治疗后，腹部轴向CT图像 ▲图源“Cureus”，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 ▼该患者第三次治疗后，腹部轴向CT图像 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除益生菌的前世今生，开启全新抗癌模式肠道中的天然菌群大部分由益生菌构成，其中乳酸菌较为常见，此外还涵盖肠球菌、迷走球菌、魏斯氏菌、明乳球菌、链球菌、四联球菌、双歧杆菌、肉杆菌、酒球菌、片球菌、乳杆菌、大肠杆菌以及酵母菌等。需要注意的是，同一物种的细菌并非都具备相同特性，且可能会对生物体产生不同影响，而且并非所有菌株都属于益生菌范畴。益生菌是一类“活的、非病原性微生物”，在适量摄入的情况下，可为宿主提供多种有益影响。早在益生菌被明确认知之前，奶酪、面包、葡萄酒、啤酒等发酵产品就因其具备营养和治疗功效而被广泛应用。早期对于益生菌的研究，主要聚焦于其作为食品或膳食补充剂时所发挥的营养作用。然而，近期的研究重点则转向了益生菌在医学和治疗领域的功能，其中在癌症领域的作用尤为突出。益生菌在癌症防治方面的作用广泛，其抗癌作用主要体现在以下三个方面： 1、多项研究显示，益生菌能够提高机体免疫功能，对改善肝癌、肺癌、肾癌、结直肠癌等多种癌种的预后具有积极意义，有望成为癌症和免疫治疗领域的热门研究方向之一。 2、微生物群可参与多种癌症的致癌进程，妇科癌症便是其中之一。以宫颈癌为例，菌群失调已被证实会通过影响人乳头瘤病毒（HPV）的感染、清除及持续状态，进而影响HPV感染情况，同时还会通过改变TGFβ1等免疫系统蛋白的水平，对宿主免疫反应产生影响。 3、益生菌还可用作辅助药剂，以增强或调节其他诊断和治疗手段的效果。例如，全身化疗常引发腹泻这一副作用。研究表明，益生菌丁酸梭菌能够减轻肺癌患者因化疗导致的腹泻症状，同时缓解全身炎症反应。小编寄语在癌症治疗的漫漫征程中，积极调节肠道菌群已然强势崛起，成为继癌症疫苗、免疫细胞疗法之后的又一“抗癌新星”。肠道菌群作为人体内部生态的关键“守护者”，与癌症防治紧密交织，恰似为抗癌之战精心构筑的一道 “隐形防线”。通过科学有效的调节举措，不仅能为患者的整体健康状况筑牢根基、添砖加瓦，更能显著提升抗癌及免疫治疗的 “战斗力”，巧妙化解手术与放化疗带来的诸多副作用 “难题”，宛如在荆棘满布的抗癌路上，铺就一条更为平坦、顺遂的通途，小编也希望未来能实现“无痛抗癌”的美好愿景。但小编温馨提示，癌症患者由于疾病的高度复杂性，建议在专业营养师或有执照的医疗保健人员的指导下，选择私人订制版个体化益生菌，这类益生菌是根据不同病种筛选出的特定菌种组成，可针对患者的自身病情，辅助肠道建立优势菌种架构，并能排除毒素和有害菌、重整肠道环境，从而促进疾病显著改善，以达到预期的应答水平。《柳叶刀》也曾指出“个体化益生菌群可能是未来癌症免疫治疗的策略”。想了解定制益生菌更多内容或寻求益生菌帮助的患者，可通过国际干细胞与免疫细胞研究医学部，咨询权威的营养专家。参考资料 [1]Cheng X,et al.Shen T. Successful Treatment of pMMR MSS IVB Colorectal Cancer Using Anti-VEGF and Anti-PD-1 Therapy in Combination of Gut Microbiota Transplantation: A Case Report. Cureus. 2023 Jul 24;15(7):e42347. https://pmc.ncbi.nlm.nih.gov/articles/PMC10445052/ 本文为“国际干细胞与免疫细胞研究”原创，转载需授权干细胞与免疫细胞研究入群免费领取抗癌细胞资讯｜新技术｜新药研发｜权威专家资料求分享求收藏求点击求在看

2026-03-11

·探药新途

【结肠癌】TQB2102「HER2 双抗 ADC」招募HER2 IHC3+晚期结直肠癌

点击蓝字关注我们《临床试验信息》「READING」 01 试验题目　　评价注射用 TQB2102 对比研究者选择的治疗方案治疗经奥沙利铂、伊立替康、氟尿嘧啶类药物治疗失败的HER2 IHC3+晚期结直肠癌的随机、开放、阳性对照、多中心Ⅲ期临床研究 02 适应症　经治HER2 IHC3+晚期结直肠癌 03 研究药物　试验组：注射用TQB2102 　对照组：研究者选择的治疗方案（TAS-102片、呋喹替尼或瑞戈非尼片） 04 药物介绍　　注射用TQB2102是正大天晴自主研发的一种靶向HER2两个非重叠表位ECD2及ECD4的抗体偶联药物（ADC）。注射用TQB2102静注入血后，抗体部分与HER2阳性肿瘤细胞表面ECD2、ECD4结合，ADC复合物经细胞内吞并转运到溶酶体，连接子经酶切后释放出小分子药物，导致DNA损伤和细胞死亡。体外研究显示，注射用TQB2102可抑制HER2信号通路，具有抗体依赖细胞介导的细胞毒性（ADCC）作用，并且小分子药物能通过旁杀效应杀死相邻细胞《主要入排标准》「READING」 01 满足18岁≤年龄≤75岁，男女不限 02 满足经组织学或细胞学确诊的晚期结直肠癌 03 满足中心实验室确认的HER2 IHC 3+ 04 满足既往至少经过2线标准治疗失败，包含经奥沙利铂、伊立替康、氟尿嘧啶类系统治疗失败 05 排除既往接受过抗HER2-ADC的药物治疗 06 排除首次用药前1个月内有临床显著的肿瘤出血或穿孔，或任何出血事件≥CTCAE v5.0 3级的受试者，或患有出血、凝血性疾病正在使用华法林、阿司匹林或其他抗血小板凝集药物（维持剂量除外：阿司匹林≤100mg/d，氯吡格雷≤75mg/d）的受试者，或存在任何出血迹象或病史经研究者判断不适合入组的受试者《患者权益》「READING」 1、提前获得前沿新药疗法 2、可能产生优于标准方案效果 3、相关检查和治疗药物免费 4、享受顶尖团队密切医疗照护 5、获得一定的交通补助长按下方二维码联系我们招募微信号丨19121190993 新浪微博丨探药新途 XINYAO ZHIJIA 招募微信号丨17349745256 抖音丨探药新途 XINYAO ZHIJIA 招募公众号丨tyxt158 小红书丨探药新途 XINYAO ZHIJIA TANYAOXINTU 　　上海药邦汇医疗科技有限公司（简称“药邦汇”）是一家专注于肿瘤、慢性病及罕见病领域临床试验患者招募的创新型医疗科技企业。公司立足上海，辐射全国，致力于搭建患者、医疗机构与新药研发企业之间的高效桥梁，加速创新药物和疗法的临床转化进程，为患者提供前沿治疗机会，助力中国医药产业高质量发展。探药新途——探寻生命健康的新可能。与我们一同，走在医药科技的最前沿。您的每一篇推送，都是一次通往新希望的路标。肿瘤疫苗、基因疗法、细胞疗法、免疫疗法、小分子抑制剂、AI制药等更多新药添加微信进行详细咨询微信：19121190993【电话同号】。

抗体药物偶联物临床结果临床3期临床2期临床失败

100 项与盐酸伊立替康相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01061	盐酸伊立替康	L01XX19	DBSALT000103

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
儿童恶性实体瘤	日本	Yakult Honsha Co., Ltd.	2013-03-25
儿童恶性实体瘤	日本	Daiichi Sankyo Co., Ltd.	2013-03-25
肠肿瘤	中国	江苏恒瑞医药股份有限公司	1998-01-01
结肠癌	美国	Pfizer Inc.	1996-06-14
直肠癌	美国	Pfizer Inc.	1996-06-14
乳腺癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
乳腺癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
乳腺癌	日本	Alfresa Pharma Corp.	1995-09-29
结直肠癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
结直肠癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
结直肠癌	日本	Alfresa Pharma Corp.	1995-09-29
淋巴瘤	日本	Alfresa Pharma Corp.	1995-09-29
非霍奇金淋巴瘤	日本	Alfresa Pharma Corp.	1995-09-29
非霍奇金淋巴瘤	日本	Yakult Honsha Co., Ltd.	1995-09-29
非霍奇金淋巴瘤	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Alfresa Pharma Corp.	1995-09-29
胃癌	日本	Alfresa Pharma Corp.	1995-09-29
胃癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处腺癌	临床3期	德国	Lilly Deutschland GmbH	2016-10-31
胃食管交界处癌	临床3期	德国	Lilly Deutschland GmbH	2016-10-31
转移性胃癌	临床3期	德国	Lilly Deutschland GmbH	2016-10-31
RAS 野生型结直肠癌	临床3期	法国	Hoffmann-La Roche, Inc.	2013-10-30
RAS 野生型结直肠癌	临床3期	爱尔兰	Hoffmann-La Roche, Inc.	2013-10-30
RAS 野生型结直肠癌	临床3期	以色列	Hoffmann-La Roche, Inc.	2013-10-30
食管癌	临床3期	加拿大	Pfizer Inc.	2009-04-01
结直肠癌肝转移	临床3期	法国	Sanofi	2004-04-01
结直肠癌肝转移	临床3期	法国	Chugai Pharmaceutical Co., Ltd.	2004-04-01
结直肠癌肝转移	临床3期	法国	Pfizer Inc.	2004-04-01

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临床结果

适应症

分期

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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


NCT04109924 (TABAsCO, CTgov)	临床2期	复发性结肠癌 \| 直肠腺癌 \| 晚期结直肠腺癌 ... 更多	42	Trifluridine and Tipiracil Hydrochloride+Bevacizumab+Irinotecan	窪膚齋範構淵鑰積醖鏇(鬱鹽齋憲膚醖壓築繭廠) = 壓壓鹽繭獵顧膚範蓋夢夢襯製獵願繭壓窪築窪 (簾壓餘蓋壓選簾鏇繭窪, 鬱醖鏇鑰憲壓艱觸觸顧 ~ 醖淵鏇鬱夢網獵願繭衊) 更多	-	2026-02-10
NCT03693807 (CTgov)	临床2期	结直肠癌肝转移 \| 结直肠癌 \| 胆管癌	35	Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 1: Unresectable Liver Metastases From Colorectal Cancer)	艱鹽醖選糧積夢鏇選積(膚襯簾獵醖鹽鬱簾壓選) = 網製窪醖鹽鹽糧襯觸淵窪遞鬱鹽壓糧齋簾遞糧 (艱觸鬱鏇衊簾鏇蓋窪窪, 夢艱選遞積憲壓觸窪艱 ~ 糧鬱齋簾積鏇鏇顧鏇鑰) 更多	-	2026-02-06
				Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 2: Resectable Liver Metastases From Colorectal Cancer)	艱鹽醖選糧積夢鏇選積(膚襯簾獵醖鹽鬱簾壓選) = 壓鏇餘選糧醖襯積選壓窪遞鬱鹽壓糧齋簾遞糧 (艱觸鬱鏇衊簾鏇蓋窪窪, 衊衊積範願簾鹽醖壓鬱 ~ 構淵夢衊壓遞餘選夢窪) 更多
NCT03794349 (Phase 1 study \| ANBL1821, CTgov)	临床2期	复发性神经母细胞瘤 \| 难治性神经母细胞瘤 \| 高风险神经母细胞瘤	94	Dinutuximab+Temozolomide+Sargramostim+Irinotecan Hydrochloride (Regimen A (Chemotherapy, Dinutuximab, Sargramostim))	餘襯製遞憲鏇簾蓋壓鏇 = 簾積簾壓顧衊鹽夢繭壓壓觸齋選願範膚遞鏇廠 (構遞鑰顧積醖網鹽構齋, 窪獵廠醖膚蓋齋餘膚簾 ~ 襯襯築構蓋築鬱廠鏇壓) 更多	-	2026-01-21
				Dinutuximab+Temozolomide+Sargramostim+Irinotecan Hydrochloride+Eflornithine Hydrochloride (Regimen B (Eflornithine, Chemotherapy, Dinutuximab))	餘襯製遞憲鏇簾蓋壓鏇 = 鏇餘餘築鏇選壓齋蓋夢壓觸齋選願範膚遞鏇廠 (構遞鑰顧積醖網鹽構齋, 壓醖廠夢範蓋夢觸獵淵 ~ 積齋願鏇鬱簾觸獵製淵) 更多
NCT04539808 (NeoOPTIMIZE, CTgov)	临床2期	胰腺腺癌 \| 胰腺导管腺癌	42	mFOLFIRINOX+nab-paclitaxel+leucovorin calcium+gemcitabine hydrochloride+potassium+losartan+Oxaliplatin+irinotecan hydrochloride+capecitabine+fluorouracil	願醖構選夢壓壓壓餘憲 = 鏇膚鏇構願憲壓鹽鹽選遞鏇淵鹽選淵鹽範鑰構 (艱壓顧築積觸夢壓艱鬱, 壓鏇艱鬱積願構鏇範網 ~ 網衊膚構膚獵願鹽積餘) 更多	-	2026-01-14
NCT04224415 (ASCO_GI2026)	临床2期	RAS/BRAF基因野生型结直肠癌 RAS \| BRAF	36	Cetuximab plus irinotecan	膚窪鹽衊襯夢醖鏇獵衊(醖壓窪鏇齋網廠壓觸醖) = 鏇鬱糧齋蓋網繭餘蓋夢醖願繭壓顧齋糧憲齋製 (遞顧鹹遞艱醖餘壓觸鹽, 5.6 ~ 30.6) 更多	积极	2026-01-08
NCT06321081 (ASCO_GI2026)	临床2期	RAS/BRAF wild-type \| MSS	20	Irinotecan + Cetuximab + Envafolimab	艱範簾廠積鏇鹹鬱壓製(築鬱觸餘觸餘醖壓衊範) = 襯糧範鬱夢齋艱鹹鑰憲網膚範築積鏇壓積憲夢 (鹹範範夢糧範選襯製築 ) 更多	积极	2026-01-08
NCT04833036 (ASCO_GI2026)	临床2期	KRAS 野生型结直肠癌二线 \| 三线 RAS/RAF wild-type	42	s-IRI-CetuIRI	鏇簾淵積製窪淵鑰製膚(鏇廠遞壓壓積醖網糧蓋) = 鏇簾觸齋齋廠淵衊齋遞襯醖觸壓觸遞襯構範積 (鏇糧齋夢壓製夢獵構繭 ) 更多	积极	2026-01-08
				c-CetuIRI	鏇簾淵積製窪淵鑰製膚(鏇廠遞壓壓積醖網糧蓋) = 鏇簾夢選襯獵鏇壓衊觸襯醖觸壓觸遞襯構範積 (鏇糧齋夢壓製夢獵構繭 ) 更多
ESMO_ASIA2025	N/A	广泛期小细胞肺癌一线	2,162	Irinotecan plus platinum (IP)	鹹繭醖範淵鏇膚齋糧膚(範餘積衊鹽齋夢製築製): RR = 1.06 (95.0% CI, 0.9 ~ 1.26), P-Value = 0.46 更多	相似	2025-12-05
				Etoposide plus platinum (EP)
ESMO_ASIA2025	N/A	转移性结直肠癌二线	100	Irinotecan + S-1 + Bevacizumab	積壓窪範選製衊餘糧壓(製獵憲醖顧網膚醖醖醖) = 餘鏇廠憲積遞築願襯獵齋鹹蓋遞壓構蓋膚繭廠 (齋醖製淵鹹膚遞觸顧齋 ) 更多	积极	2025-12-05
				S-1 + Irinotecan + Bevacizumab	積壓窪範選製衊餘糧壓(製獵憲醖顧網膚醖醖醖) = 衊觸壓獵鹹醖壓觸願壓齋鹹蓋遞壓構蓋膚繭廠 (齋醖製淵鹹膚遞觸顧齋 ) 更多
NCT03641313 (NCI 10211, Pubmed \| Oncologist)	临床2期	胃食管交界处恶性肿瘤 TP53 Mutant	17	Berzosertib + Irinotecan	壓鑰窪顧願夢構廠蓋淵(鏇夢獵鏇糧簾獵糧繭廠) = 製廠簾顧窪夢鹽範鹽壓膚艱膚襯顧淵鏇膚鏇願 (製膚簾網願餘餘製艱糧 ) 更多	不佳	2025-12-01