A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

开始日期2025-09-24

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT06901531

/ Recruiting临床3期

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

开始日期2025-05-22

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT06881017

/ Not yet recruiting临床2期IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

开始日期2025-05-01

申办/合作机构

中国医科大学

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100 项与佐妥昔单抗相关的专利（医药）

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141

项与佐妥昔单抗相关的文献（医药）

2026-04-01·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

作者: Kimura, Rika ; Yoshioka, Tsubasa ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

2026-01-01·JOURNAL OF NUCLEAR MEDICINE

Claudin 18.2 as a Biomarker for Imaging and Radiopharmaceutical Therapy in Gastric and Pancreatic Tumors

Article

作者: Strickland, Matthew R ; Mahmood, Umar ; Haj-Mirzaian, Arvin ; Ting, David T ; Klempner, Samuel J ; Khazaei Monfared, Yousef ; Larimer, Benjamin M ; Raheem, Shvan J ; Heidari, Pedram ; Esfahani, Shadi A ; Bashyal, Santosh

Claudin 18.2 (CLDN18.2) is a tight-junction protein overexpressed and differently exposed in solid tumors such as gastric cancer (GCa), gastroesophageal junction adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC). We sought to explore the potential of CLDN18.2 as a biomarker for molecular imaging and targeted radiopharmaceutical therapy in GCa and PDAC models. Methods: Bulk and single-cell RNA sequencing for CLDN18.2 from 31 patients with PDAC were performed. Subcutaneous xenografts of GCa with the GSU cell line and PDAC with HUPT-4 and PATU8988S cell lines were developed in nude mice. Serial PET imaging with ⁸⁹Zr-labeled zolbetuximab, an anti-CLDN18.2 monoclonal antibody ([⁸⁹Zr]Zr-DFO-zolbetuximab), and human IgG ([⁸⁹Zr]Zr-DFO-IgG) as control (5.5-7.4 MBq) was performed 1, 3, and 6 d after injection, followed by ex vivo analysis of biodistribution. Tumor-bearing mice received a single intravenous injection of [¹⁷⁷Lu]Lu-DOTA-zolbetuximab (7.4 or 14.8 MBq), nonradiolabeled zolbetuximab, [¹⁷⁷Lu]Lu-DOTA-IgG, [¹⁷⁷Lu]Lu-DOTA, or saline as the control. Toxicity of [¹⁷⁷Lu]Lu-DOTA-zolbetuximab was evaluated by laboratory and histologic analyses over 90 d. Results: RNA sequencing confirmed significantly higher expression of CLDN18.2 in human PDAC compared with noncancerous pancreas tissue, with no significant difference between treated and untreated tumors. Serial PET imaging demonstrated a high tumor uptake of [⁸⁹Zr]Zr-DFO-zolbetuximab at all 3 time points (mean uptake on day 6: 24.4 ± 7.8 %ID/g in GSU; 36.6 ± 10.1 %ID/g in PATU8988S; 16.48 ± 4.7 %ID/g in HUPT-4), and significantly higher than the uptake seen in mice imaged with [⁸⁹Zr]Zr-DFO-IgG (day 6: 4.8 ± 1.9 %ID/g in GSU; P = 0.0029). The highest tumor-to-background uptake ratio was achieved on day 6 (GSU tumor-to-muscle ratio, 14.85 ± 7.8). Biodistribution analyses were consistent with the PET imaging results. High-dose [¹⁷⁷Lu]Lu-DOTA-zolbetuximab (14.8 MBq) resulted in reduced tumor growth in GSU and PATU8988S over 4 and 8 wk, respectively, with complete regression of most HUPT-4 tumors and improved 90-d survival compared with the mice treated with control conditions. The 90-day treatment toxicity assay indicated a favorable safety profile. Conclusion: CLDN18.2 could serve as a promising biomarker for precise quantitative imaging and effective treatment of GCa and PDAC. This proof-of-concept study encourages the clinical translation of CLDN18.2 as a radiotheranostic in patients with CLDN18.2-expressing tumors.

2026-01-01·Journal of Gastric Cancer

CLDN18.2 in Gastric Cancer: Current Therapeutic Landscape and Future Perspectives

Review

作者: Zhang, Fei ; Okazaki, Ukyo ; Shitara, Kohei ; Nakayama, Izuma

Claudin 18.2 (CLDN18.2), a tight junction protein selectively expressed in normal gastric epithelium and widely retained during carcinogenesis, has emerged as a promising therapeutic target for advanced gastric cancer (AGC). SPOTLIGHT and GLOW trials evaluated the anti-CLDN18.2 monoclonal antibody (mAb) zolbetuximab in combination with first-line chemotherapy, and established CLDN18.2 as a therapeutic target, initiating a paradigm shift toward a biomarker-driven treatment approach in AGC. In addition, from zolbetuximab to a diverse pipeline of promising high-affinity mAbs, bispecific antibodies, antibody-drug conjugates and chimeric antigen receptor T cells, this target has established a new and highly effective therapeutic avenue for CLDN18.2-expressing AGC. Therefore, as research progresses, CLDN18.2-targeted therapy is poised to become a cornerstone of treatment across multiple disease stages and cancer types. This review describes the biological role of CLDN18.2 in normal gastric epithelium and gastric carcinogenesis and summarizes the current therapeutic landscape and future perspectives targeting CLDN18.2 in AGC.

457

项与佐妥昔单抗相关的新闻（医药）

2026-02-04

·肿瘤资讯

CLDN18.2：胃食管癌治疗领域的“新星”崛起——从靶点验证到多元化药物开发

整理：肿瘤资讯来源：肿瘤资讯2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）于美国旧金山召开。来自韩国首尔国立大学医院的Do-Youn Oh教授在大会现场发表了题为“Claudin 18.2 Therapies for Gastroesophageal Cancer: New Kid on the Block”的专题演讲，系统阐述了CLDN18.2作为胃食管癌新兴治疗靶点的生物学特征、已获批药物的临床证据、靶向治疗相关毒性的管理策略，以及单克隆抗体、抗体药物偶联物（ADC）、双特异性抗体和嵌合抗原受体T细胞（CAR-T）等多元化治疗平台的研发进展。这一演讲为临床医生和研究者全面呈现了CLDN18.2靶向治疗的当前格局与未来方向，具有重要的学术参考价值。【肿瘤资讯】特此整理讲题重要内容。CLDN18.2的生物学特征：瘤内异质性与免疫微环境CLDN18.2是一种紧密连接蛋白，近年来已被证实为胃食管癌领域的新型治疗靶点。Do-Youn Oh教授在演讲开篇即指出，目前已有获批的CLDN18.2靶向药物进入临床应用，同时多种作用机制的靶向制剂及新型联合治疗策略正在积极探索中，以期进一步改善患者的临床结局。在CLDN18.2的生物学特征方面，Do-Youn Oh教授重点强调了瘤内异质性问题。研究显示，当采用全切片与组织芯片进行表达模式比较时，在至少一个芯片核心呈CLDN18.2阳性的病例中，61.3%存在异质性表达。此外，CLDN18.2阳性胃癌的免疫微环境呈现独特特征：与阴性肿瘤相比，CLDN18.2阳性肿瘤的外周区域CD3+和CD4+ T细胞密度更高，肿瘤中心区域CD8+ T细胞密度亦更高，这一发现为后续联合免疫治疗策略提供了理论依据。靶点验证：两项全球III期研究奠定CLDN18.2治疗地位CLDN18.2之所以被确立为胃食管癌的新靶点，源于两项全球III期临床研究SPOTLIGHT和GLOW的阳性结果。这两项研究纳入HER2阴性、CLDN18.2阳性（≥75%的肿瘤细胞膜中等-强着色）的晚期胃或胃食管结合部腺癌患者，在化疗基础上联合佐妥昔单抗一线治疗可使患者的死亡风险降低约25%（图1），且未对健康相关生活质量（HRQoL）产生负面影响（图2）。图1 SPOTLIGHT和GLOW研究的OS图2 健康相关生活质量（HRQoL）靶向治疗相关毒性：CLDN18.2相关性胃炎的识别与管理然而，CLDN18.2靶向治疗的“on-target off-tumor”毒性需要临床高度关注，其中最具特征性的是CLDN18.2相关性胃炎。Do-Youn Oh教授指出，CLDN18.2相关性胃炎是该靶点靶向治疗的共性毒性。内镜评估显示，单抗最常见的表现为黏膜红斑，其次为糜烂、水肿和白色渗出物，约70%的患者同时呈现多种特征。在接受CLDN18.2 T细胞衔接器治疗8周后，内镜随访同样可见黏膜糜烂、水肿和红斑，活检显示伴有消化性碎屑的炎性肉芽组织。类似地，CLDN18.2 ADC治疗6周后的内镜随访亦显示黏膜糜烂，活检呈活动性胃炎伴炎性肉芽组织，停药约4周后胃黏膜可有所改善。这种胃炎与更高的胃肠道毒性相关，包括厌食、恶心、呕吐加重及白蛋白水平下降。因此，早期积极干预恶心、呕吐对于维持治疗至关重要，措施包括使用强效止吐药、调整输注速度以及必要时中断输注。单克隆抗体：从佐妥昔单抗到联合免疫治疗的探索在CLDN18.2靶向药物的开发方面，Do-Youn Oh教授介绍了单克隆抗体、ADC、双特异性抗体和CAR-T四大类别。目前，佐妥昔单抗是唯一获批的CLDN18.2单克隆抗体。为进一步改善患者的预后，联合免疫检查点抑制剂（ICI）的策略正在积极探索。根据CLDN18.2和PD-L1表达状态的不同组合，肿瘤免疫微环境呈现多样化特征，这为联合治疗提供了理论支持。2026 ASCO GI大会上报告了ILUSTRO II期研究队列4的结果，该研究评估了佐妥昔单抗联合mFOLFOX6和纳武利尤单抗的疗效（图3），结果显示该联合方案具有令人鼓舞的抗肿瘤活性和可控的安全性。目前，全球III期研究LUCERNA正在进行，该研究纳入了HER2阴性、CLDN18.2阳性、PD-L1 CPS≥1的患者，随机接受化疗联合帕博利珠单抗±佐妥昔单抗一线治疗（图3）。图3 佐妥昔单抗联合化疗和免疫治疗探索其他单克隆抗体亦在研发中。Osemitamab（TST001）是其中的代表，其对CLDN18.2和Fc受体的亲和力高，可产生很强的抗体依赖性细胞毒性（ADCC）和补体依赖性细胞毒性（CDC）效应。在肿瘤小鼠模型和患者来源异种移植（PDX）模型中，Osemitamab联合化疗和PD-1抑制剂显示出良好的抗肿瘤活性。TranStar102研究在HER2阴性患者（不限CLDN18.2和PD-L1表达状态）中评估了Osemitamab联合化疗和PD-1抑制剂一线治疗的疗效。在所有患者中，采用≥2+/≥40%标准定义的CLDN18.2高表达亚组客观缓解率（ORR）达68%，中位缓解持续时间（mDOR）为18个月，中位无进展生存期（PFS）为16.6个月。亚组分析显示，PD-L1 CPS≥1的患者和CLDN18.2高表达患者均呈现更优的PFS趋势（图4）。当前TranStar 301 III期研究（一线治疗）已在规划中。图4 TranStar102研究的PFS抗体药物偶联物（ADC）：靶点表达cut-off值的确定与应用探索ADC作为靶向CLDN18.2的另一重要手段，其活性与CLDN18.2表达水平密切相关。Do-Youn Oh教授指出，在胃癌细胞系中，CLDN18.2的表达通常较低，仅SNU-601细胞系具有较高的内源性表达。研究显示，在同一细胞系中通过转染构建不同CLDN18.2表达水平的细胞后，ADC的活性与CLDN18.2表达水平呈良好相关性，提示在开发CLDN18.2 ADC时，靶点表达cut-off值的确定是关键问题。目前多种CLDN18.2 ADC正在研发中，以SHR-A1904、CMG0901/AZD0901和IBI343为代表，它们具有不同的载荷和Fc效应功能特征。需要指出的是，不同临床试验对CLDN18.2阳性的定义及高表达与低表达的分界标准差异较大，目前尚无统一共识。在CLDN18.2阳性复发性胃癌的治疗中，上述三种ADC单药治疗的ORR为19.3%～33%，部分情况下可达47%；mPFS为5~6个月，mOS为10~11个月（图5）。在安全性方面，ADC最常见的不良事件为血液学毒性；SHR-A1904、CMG0901/AZD0901和IBI343的3-4级恶心的发生率分别为4.2%、4%和1.7%，3-4级呕吐的发生率分别为5.3%、10%和2.6%。目前已有多项III期研究正在进行，评估CLDN18.2 ADC在二线及以上治疗中的疗效，对照组为研究者选择的化疗方案，试验组为上述三种ADC单药治疗。图5 三款CLDN18.2 ADC单药治疗CLDN18.2阳性复发性胃癌的OS一线治疗领域，有研究在HER2阴性、CLDN18.2阳性患者中评估了CLDN18.2 ADC JS107联合XELOX和特瑞普利单抗的疗效和安全性。结果显示，总体ORR为80%；采用≥2+/40%标准定义的CLDN18.2高表达人群的ORR达86.7%，mPFS超过11个月（图6），治疗相关不良反应（TRAEs）可控。基于这些结果，一项III期临床试验已在规划中，拟在一线CLDN18.2高表达患者中验证该联合方案的疗效。图6 CLDN18.2 ADC JS107+XELOX+特瑞普利单抗一线治疗PFS双特异性抗体：T细胞衔接器与4-1BB双抗的双轨并进双特异性抗体是靶向CLDN18.2的又一重要手段，其中CLDN18.2×CD3 T细胞衔接器是当前药物研发的热点领域。Do-Youn Oh教授以IBI389、AZD5863、ASP2138、AMG910等为例介绍了不同T细胞衔接器的独特结构。在CLDN18.2阳性复发性胃癌的治疗中，T细胞衔接器单药治疗的初步数据显示，IBI389的ORR为30.8%，DCR为73.1%，mPFS为3.5个月（图7）。目前，T细胞衔接器正在与化疗联合或与免疫治疗联合进行探索。图7 IBI389治疗CLDN18.2阳性复发性胃癌除了T细胞衔接器外，4-1BB双特异性抗体是另一值得关注的药物。研究发现，CLDN18.2阳性肿瘤细胞与4-1BB+/CD4+ T细胞及4-1BB+/CD8+ T细胞在空间上紧密相邻。基于此，CLDN18.2×4-1BB双特异性抗体Givastomig在CLDN18.2阳性复发性胃癌治疗中进行了单药探索，确认的ORR为16%，即使未常规预防性使用止吐药，恶心、呕吐反应仍轻微（3-4级 1%）。在CLDN18.2阳性胃癌中，Givastomig联合纳武利尤单抗和mFOLFOX6方案一线治疗的ORR达71%～83%（剂量递增/扩展），不良反应良好（无3-4级恶心、呕吐）（图8）。鉴于此，随机对照研究已在规划中。图8 Givastomig+纳武利尤单抗+mFOLFOX6一线治疗CLDN18.2阳性胃癌CAR-T治疗：Satri-cel的突破与未来优化方向CAR-T治疗是靶向CLDN18.2的前沿领域，但在胃食管癌中的应用面临诸多挑战，包括肿瘤微环境特征、抗原异质性、CAR-T细胞的运输与浸润、持久性问题、相关毒性、高昂的生产成本，以及缺乏标准化方案和监管协调。尽管如此，Satri-cel（CLDN18.2 CAR-T）的阳性结果表明，CAR-T在胃食管癌中的应用是可行的。在一项开放标签、多中心、随机对照研究中，晚期胃癌患者（CLDN18.2表达采用2+、3+/≥40%标准）按2:1比例随机接受CLDN18.2 CAR-T Satri-cel或医生选择的化疗方案三线及以上治疗。结果显示，Satri-cel组PFS显著改善（mPFS 3.25个月 vs 1.77个月），同时带来具有临床意义的OS获益（mOS 7.92个月 vs 5.49个月）（图9），ORR为30%，而对照组仅为4%。在机制层面，研究发现外周血中存在特定的中性粒细胞亚群，在Satri-cel输注后第3天和第7天扩增，抑制初始T细胞功能，可能与CAR-T耐药相关。在安全性方面，Satri-cel组TRAEs发生率较高，但多为1-2级，主要的3-4级TRAEs为血液学毒性。大部分患者发生了细胞因子释放综合征（CRS），但3-4级CRS仅为4.5%。图9 CLDN18.2 CAR-T Satri-cel三线及以上治疗的PFS、OSDo-Youn Oh教授指出，CAR-T细胞治疗目前仍存在诸多局限，包括部分患者因疾病快速进展无法在采集后完成输注，提示在生产工艺和采集时机方面仍有较大改进空间。理论上，CAR-T的优化方向包括逆转肿瘤微环境、联合其他作用机制药物（如T细胞衔接器、免疫检查点抑制剂、ADC和疫苗），以及探索通用型CAR-T细胞。目前，多项CLDN18.2 CAR-T临床试验正在胃食管癌领域开展。结语（未满足的临床需求与未来方向）在总结中，Do-Youn Oh教授强调，CLDN18.2是胃食管癌治疗领域的“新星”，但该领域仍存在迫切的未满足需求，包括瘤内异质性问题、最佳表达cut off值的确定、耐药机制的阐明，以及“on-target off-tumor”毒性的管理。未来，采用不同作用机制药物的新型联合策略将是改善患者预后的关键方向。责任编辑：肿瘤资讯-Marie 排版编辑：肿瘤资讯-Marie 版权声明版权归肿瘤资讯所有。欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明“转自：良医汇-肿瘤医生APP”。

免疫疗法抗体药物偶联物细胞疗法临床3期ASCO会议

2026-02-04

·ONCO前沿

免疫治疗与精准医学时代下食管及胃食管结合部腺癌的综合治疗新格局：从局部进展期到转移期

近年来，随着免疫检查点抑制剂及多种分子靶向药物在胃肠道肿瘤领域的突破性进展，食管及胃食管结合部腺癌的整体治疗策略正经历深刻变革。传统以手术和放化疗为核心的局部治疗模式，逐步向以全身治疗为主导、融合分子分型与生物标志物指导的精准综合治疗转型。围手术期强化化疗、免疫治疗联合方案以及新型靶向治疗的引入，不仅显著改善了局部进展期患者的长期生存预后，也重塑了转移期疾病的一线与后线治疗格局。在这一快速演进的治疗背景下，如何基于肿瘤生物学特征、分子分型及患者个体化因素制定最优治疗路径，已成为多学科协作管理的核心议题。在上述治疗范式不断更新的背景中，以下病例系统展示了一例胃食管结合部腺癌患者从初诊时的局部进展期，经新辅助综合治疗、根治性手术及术后随访，直至远处转移后的系统治疗全过程。该病例不仅体现了当前循证医学证据指导下的治疗决策逻辑，也反映了真实临床实践中多学科协作、治疗策略动态调整及长期疾病管理所面临的复杂挑战。本病例为一名55岁男性，既往病史包括高血压、高脂血症、创伤后应激障碍、阿片类药物使用障碍（维持治疗中）及吸烟依赖。患者于2023年因进行性固体食物吞咽困难3个月就诊于急诊科，无呕血、呼吸困难或体重下降。ECOG体能状态评分为0。实验室检查包括生化及血常规均正常。急诊行食管胃十二指肠镜检查，发现胃食管结合部存在近乎完全阻塞的肿块，向近端侵及远端食管约5 cm，活检证实为中分化腺癌。免疫组化显示HER2阴性，错配修复蛋白完整，PD-L1检测联合阳性评分为5–9。颈胸腹盆腔CT显示胃食管结合部结节样增厚及上腹部淋巴结肿大，胃肝韧带结最大约1 cm，胃贲门旁及腹主动脉旁见亚厘米级结节，无明确远处转移证据。随后行内镜超声，分期为cT3N2。PET/CT示远端食管及胃食管结合部肿块及上腹部和左腋窝淋巴结高代谢，左腋窝结节穿刺提示反应性淋巴组织，考虑近期新冠疫苗接种相关。腹腔镜探查未见腹膜转移，最终临床分期为cT3N2M0，AJCC第8版Ⅲ期胃食管结合部腺癌。经胸外科及多学科讨论后，决定行根治性三联治疗，即新辅助放化疗后行食管切除术。因吞咽困难严重，患者先接受3周期诱导化疗FOLFOX方案，症状显著缓解，随后行同步放疗联合FOLFOX新辅助放化疗。治疗后PET显示肿瘤体积及代谢显著下降，随后行微创食管切除术。术后病理未见残余癌灶，19枚淋巴结均阴性，病理分期为ypT0N0，达到病理完全缓解，因此未根据CheckMate 577研究给予辅助纳武利尤单抗，进入规律影像随访。术后10个月复查CT发现多发新发肺结节及左肝2.6 cm转移灶并腹膜后淋巴结肿大，肝穿刺证实转移性腺癌，免疫组化显示CLDN18.2表达>75%，PD-L1 CPS 5–9。二代测序发现多种体细胞突变，但无现有靶向药可直接应用，其中ERBB3及PIK3CA存在潜在可靶向突变。患者开始接受FOLFOX联合纳武利尤单抗治疗，5周期后CT显示肺及肝转移明显缩小，达到部分缓解。其治疗过程伴有焦虑、抑郁及创伤后应激症状，术后体重难以恢复，需再次置入空肠造瘘管，在社会工作、姑息医学、心理肿瘤学及营养团队支持下持续治疗。局部晚期胃食管结合部腺癌的治疗策略依赖多学科评估，需综合组织学类型、分子分型、分期、肿瘤部位及患者对手术耐受性等因素。Ⅰ期患者通常直接手术；Ⅱ–Ⅲ期鳞癌可采用新辅助放化疗后手术或根治性放化疗；而Ⅱ–Ⅲ期错配修复功能完整的腺癌，治疗范式已逐渐从新辅助放化疗转向围手术期化疗，放化疗主要用于不适合手术或拒绝手术者。错配修复缺陷或MSI高的局部进展期患者可优先考虑新辅助免疫治疗，并在达到完全缓解时探索器官保留策略。过去20年，多项随机研究奠定了围手术期化疗或新辅助放化疗作为标准策略。MAGIC研究显示围手术期ECF/ECX较单纯手术显著改善生存；FLOT4研究用FLOT方案进一步提高疗效；CROSS研究证实新辅助放化疗可改善总体生存，但腺癌的病理完全缓解率仅约23%。CALGB 80803研究提示诱导FOLFOX联合同步放疗可获得40%的病理完全缓解率及53%的5年生存率。随后NEO-AEGIS及TOPGEAR研究显示围手术期化疗与新辅助放化疗生存相当。ESOPEC研究首次在纯胃食管结合部腺癌人群中证实围手术期FLOT较新辅助放化疗具有生存优势，使围手术期化疗成为新标准。MATTERHORN研究进一步证实在FLOT基础上联合度伐利尤单抗可显著提高事件无进展生存，预示免疫联合化疗将成为新的标准模式。病理学评估在该病管理中至关重要。诊断时常规检测错配修复蛋白、HER2、PD-L1及CLDN18.2，以指导转移期生物制剂选择。错配修复缺陷提示免疫治疗高度敏感；PD-L1 CPS用于预测免疫治疗获益，但存在较大异质性；HER2阳性可使用曲妥珠单抗；CLDN18.2阳性患者可使用佐贝妥昔单抗。NGS检测用于发现少见可靶向突变。术后需全面评估肿瘤床及淋巴结以准确判定病理完全缓解。在转移期，标准一线治疗为含氟嘧啶及铂类的化疗联合生物制剂，选择依据MMR、HER2、PD-L1及CLDN18.2状态。HER2阳性患者可用曲妥珠单抗联合化疗，PD-L1阳性者联合PD-1抑制剂，CLDN18.2阳性者联合佐贝妥昔单抗。PD-L1 CPS≥5者从免疫治疗中获益最明显。二线治疗包括雷莫芦单抗联合紫杉醇或FOLFIRI，HER2阳性者可用T-DXd，鼓励进入临床试验探索新型双特异抗体、ADC及细胞治疗。放射肿瘤学角度强调，放疗在局部控制及可能的免疫增敏中仍有潜在价值。对于存在非区域淋巴结转移但可纳入照射野的患者，可考虑根治性放化疗。广泛淋巴结受累时，放疗有助于清除潜在微小病灶，但需权衡毒性风险。胸外科视角认为，微创食管切除术死亡率已降至2%以下，90%以上可实现阴性切缘，但能否真正改善长期生存仍取决于微转移控制。本病例术后短期内出现全身进展，引发对是否应行手术的反思。SANO研究提示部分达到完全临床缓解的患者可通过密切随访避免立即手术，如何筛选真正可免于手术切除食管者仍是研究重点。心理肿瘤学方面，患者既往创伤史及疾病对生活质量的严重冲击导致明显癌症相关创伤后应激障碍。通过认知行为治疗、接纳承诺疗法及药物干预，改善其焦虑抑郁，提升治疗依从性和生活质量。目前患者耐受FOLFOX联合纳武利尤单抗良好，转移灶持续部分缓解，体重增加，恢复进食并重返工作，体能状态评分1。长期随访数据显示，PD-L1 CPS≥5患者接受该方案后5年生存率可达16%。综上，局部晚期胃食管结合部腺癌需多学科协作管理，当前标准为围手术期化疗，未来可能联合免疫治疗。转移期治疗应以生物标志物为导向，精准选择治疗方案。尽管治疗取得进展，仍亟需开发更有效的靶向和免疫策略，并优化患者心理支持与生活质量管理。内容参考 1.DOI: 10.3322/caac.70050 责任编辑丨郭筝版权声明：本平台旨在帮助医疗卫生专业人士更好地了解相关疾病领域最新进展。本平台对发布的资讯内容，并不代表同意其描述和观点，仅为提供更多信息。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。仅供医疗卫生专业人士为了解资讯使用，该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解资讯以外的目的，本平台及作者不承担相关责任。合作联系邮箱：ONCO@edoctor.work。点击"阅读原文"即可看原文

免疫疗法疫苗临床3期

2026-01-31

·肿瘤科倪大夫

关于Claudin 18.2靶向胃癌，了解这些新兴的生物制剂

1.关于胃癌胃癌（gastric cancer，GC）是全球癌症相关死亡的第四大原因，迫切需要新的治疗策略。尽管在诊断和治疗方面取得了进展，但晚期胃癌的预后仍然不佳。目前的治疗选择有限，主要包括化疗、抗HER2治疗和免疫检查点抑制剂。然而，很大一部分患者无法从这些治疗中获益，凸显了对新治疗靶点的迫切需求。 2. Claudin 18.2生物学与病理生理学 Claudins是形成紧密连接的跨膜蛋白家族，对维持上皮细胞极性和屏障功能至关重要。CLDN18.2是CLDN18的亚型，在正常的胃黏膜上皮细胞中特异性表达。在胃癌发生过程中，由于细胞极性的丧失，CLDN18.2暴露于细胞外环境，成为理想的治疗靶点。CLDN18.2的表达与弥漫型组织学、年轻年龄和腹膜转移等临床病理特征相关。CLDN18.2在约70%的胃癌中持续表达，使其成为一种有吸引力的非致癌驱动治疗靶点。 3. Zolbetuximab：首个获批的抗Claudin 18.2单克隆抗体 Zolbetuximab是首个获批的抗CLDN18.2单克隆抗体，已确立了HER2阴性、CLDN18.2阳性晚期胃癌患者一线治疗的新标准。Zolbetuximab是一种嵌合的IgG1单克隆抗体，通过抗体依赖性细胞介导的细胞毒性和补体依赖性细胞毒性机制，特异性地结合CLDN18.2并诱导细胞溶解。两项关键的III期临床试验（SPOTLIGHT和GLOW）确立了Zolbetuximab联合化疗在HER2阴性、CLDN18.2阳性（定义为≥75%的肿瘤细胞中等至强膜染色）的局部晚期或转移性胃癌或胃食管结合部癌患者一线治疗中的地位。 SPOTLIGHT研究是一项全球性III期试验，招募了约550名CLDN18.2阳性、HER2阴性的晚期胃癌患者。其中，CLDN18.2阳性定义为≥75%的肿瘤细胞显示中度至强CLDN 18.2染色。研究按1:1将患者随机分为两组。试验组为佐妥昔单抗+mFOLFOX6；对照组为安慰剂+mFOLFOX6。主要终点为PFS。 PFS：佐妥昔单抗组的中位PFS为11.0个月，安慰剂组为8.9个月。 OS：佐妥昔单抗组的中位OS为18.2个月，安慰剂组为15.6个月。 GLOW研究是一项全球、多中心、随机双盲、安慰剂对照的III期临床试验，旨在评估佐妥昔单抗联合CAPOX（卡培他滨+奥沙利铂）方案在CLDN18.2阳性、HER2阴性的局部晚期不可切除或转移性胃癌或胃食管结合部腺癌（GC/GEJC）患者中的疗效和安全性。研究参与者以1:1的比例随机分配至以下两组：治疗组：佐妥昔单抗联合CAPOX方案，共254例患者。对照组：安慰剂联合CAPOX方案，共253例患者。在完成8个周期的治疗后，患者继续接受佐妥昔单抗+卡培他滨或安慰剂+卡培他滨的维持治疗。无进展生存期（PFS）：佐妥昔单抗联合CAPOX组的中位PFS为8.21个月，安慰剂联合CAPOX组为6.80个月，疾病进展或死亡风险降低了31.3%。总生存期（OS）：佐妥昔单抗联合CAPOX组的中位OS为14.39个月，安慰剂联合CAPOX组为12.16个月，死亡风险降低了22.9%。 4. Zolbetuximab相关胃炎：病理生理机制与管理 Zolbetuximab相关胃炎是由于Zolbetuximab结合并破坏正常胃黏膜上皮细胞（也表达CLDN18.2）引起的，属于“靶向非肿瘤”（on-target, off-tumor）毒性。Zolbetuximab相关胃炎的特点是恶心、呕吐和食欲不振等症状的发生率高（>60%），尤其是在首次输注后不久。内镜检查显示胃黏膜充血、糜烂和溃疡。组织病理学检查显示炎症细胞浸润和上皮损伤。管理策略：Zolbetuximab相关胃炎通常是短暂的且可逆的。关键的管理策略包括：*预防性抗呕吐治疗*：使用包含NK1受体拮抗剂、5-HT3受体拮抗剂、地塞米松和奥氮平等在内的多药联合方案进行预防。*阶梯式输注*：缓慢增加输注速度以减轻急性反应。*支持性护理*：使用质子泵抑制剂和粘膜保护剂。*剂量调整*：根据毒性严重程度暂停或终止治疗。5. 下一代Claudin 18.2靶向治疗尽管Zolbetuximab取得了成功，但仍存在一些局限性，如靶点表达下调、对低表达患者的疗效有限以及输液相关反应等。目前正在开发下一代生物制剂以克服这些局限性。*新一代单克隆抗体*：Osemitamab（TST001）和ASKB589等新一代单克隆抗体经过工程改造，增强了与Fcγ受体的结合，从而增强了ADCC活性。这些抗体在CLDN18.2低表达的肿瘤中也显示出活性。Osemitamab (TST001)是第二个在全球范围内开发的CLDN18.2靶向抗体药物，美国食品和药品监督管理局(FDA)已授予Osemitamab (TST001)用于治疗胃或胃食管结合部腺癌和胰腺癌患者的孤儿药资格认定。*抗体-药物偶联物（ADCs）*：ADCs将抗CLDN18.2抗体与强效细胞毒药物通过连接子连接。ADCs通过靶点介导的内吞作用进入细胞，释放细胞毒药物以诱导细胞死亡。ADCs具有“旁观者效应”，可以杀死邻近的抗原阴性肿瘤细胞。代表性的ADCs包括AZD0901（Imotuzimab deruxtecan）、SHR-A1904、LM-302和AB021。初步数据显示，ADCs在二线及以后的治疗中具有良好的疗效。*双特异性抗体*：双特异性抗体可以同时结合CLDN18.2和免疫细胞上的靶点（如CD3），从而将免疫细胞募集到肿瘤部位。IBI389（CLDN18.2/CD47）、ASP2138（CLDN18.2/CD3）和Givastomig（CLDN18.2/CD3）等双特异性抗体正在临床开发中。这些药物具有强大的抗肿瘤活性，但也需要警惕细胞因子释放综合征（CRS）等免疫相关毒性。*嵌合抗原受体T细胞疗法（CAR-T）*：CAR-T细胞疗法是一种个性化的细胞疗法，通过基因工程改造患者的T细胞，使其表达能特异性识别CLDN18.2的嵌合抗原受体。Satrical（CT041）是首个在随机对照试验中证明对实体瘤（胃癌）有效并优于标准治疗的CAR-T疗法。在一项针对既往治疗过的CLDN18.2阳性消化系统肿瘤的随机II期试验中，Satrical显著改善了研究者评估的无进展生存期（4.5 vs 1.3个月；HR 0.40；P=0.002）。6. 关键问题与未来展望*动态靶点表达*：CLDN18.2表达可能在化疗或Zolbetuximab治疗后下调。因此，可能需要进行再活检以指导后续治疗。*扩大受益人群*：目前的诊断标准要求较高的CLDN18.2表达比例（≥75%）。新一代疗法（如ADCs和双特异性抗体）可能对CLDN18.2低表达的患者也有效，从而扩大受益人群。*联合治疗策略*：探索CLDN18.2靶向治疗与化疗、免疫治疗、靶向治疗等的联合应用是未来的研究方向。例如，Zolbetuximab联合PD-1抑制剂的试验正在进行中。*最佳治疗序列*：随着越来越多的CLDN18.2靶向疗法获批，确定最佳的治疗序列（如单抗→ADC→CAR-T）对于最大化患者获益至关重要。参考文献 Targeting claudin 18.2 in gastric cancer: a review of emerging biologic agents（PMID: 41542901）

临床3期临床结果临床成功

100 项与佐妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	佐妥昔单抗	-	DB15118

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
晚期胃食管交界处腺癌	加拿大	Astellas Pharma Canada, Inc.	2025-01-09
CLDN18.2阳性胃食管交界处腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃癌	日本	Astellas Pharma, Inc.	2024-03-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期胃食管交界处腺癌	临床3期	美国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	中国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	日本	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	阿根廷	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	克罗地亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	希腊	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	爱尔兰	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	马来西亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	荷兰	Astellas Pharma Global Development, Inc.	2018-11-28

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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


NCT06901531 (LUCERNA, ASCO_GI2026)	临床3期	局部晚期胃食管交界处腺癌 \| PD-L1阳性实体瘤 \| CLDN18.2阳性胃腺癌一线 CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	餘築糧齋製糧齋餘衊窪(衊簾醖遞繭糧艱淵繭憲) = 淵壓憲膚憲鏇蓋構積糧獵網齋顧簾餘醖廠簾網 (製選築壓願鹽構鹹襯醖, 24.9 ~ NR)	积极	2026-01-08
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	餘齋網築鹹構簾製衊積(鏇廠網獵廠構簾襯願憲) = 鏇製夢夢艱艱鬱網廠鹹糧夢衊觸蓋膚範顧鏇鹽 (夢鏇壓範醖製製構鹹餘, 43.1 ~ 56.9) 更多
ESMO_ASIA2025	N/A	晚期胃食管交界处腺癌一线	22	Zolbetuximab (Zolb) + chemo	膚網選製繭艱網顧構廠(願憲鏇壓觸衊簾願蓋衊) = abdominal pain (18%) 憲艱選窪鹽醖鏇壓蓋鹽 (網衊鏇窪膚範衊觸範餘 ) 更多	积极	2025-12-05
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃腺癌一线 CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	觸衊選鹽鹹顧簾範鑰襯(獵顧築積簾願選積選獵) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). 鏇鑰範願衊積鑰遞壓憲 (範憲壓醖觸膚醖獵蓋窪 ) 更多	积极	2025-12-05
				Placebo plus mFOLFOX6/CAPOX
ESMO_ASIA2025	N/A	晚期胃癌	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	壓築顧淵襯膚醖衊淵鹹(糧顧鑰窪壓願糧構鹹鏇) = 餘製糧築醖壓廠製繭選範築網淵壓鹹簾鹹鏇窪 (淵鏇願網觸繭蓋艱衊醖 ) 更多	积极	2025-12-05
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	临床3期	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	膚選窪製鬱選鏇艱願糧(觸繭築顧築積艱顧鏇鏇) = 範醖選網憲憲觸窪壓鏇齋願構襯鹽餘鏇膚襯簾 (選鏇憲觸獵蓋衊蓋憲廠, 夢膚襯簾繭夢鏇範製窪 ~ 夢鹽鬱築衊願膚鹽齋膚) 更多	-	2025-02-26
NCT03653507 (GLOW, CTgov)	临床3期	局部晚期胃食管交界处腺癌 \| 转移性胃食管结合部腺癌	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	網壓膚鏇選築獵糧築壓(顧構顧製蓋醖淵鑰齋鹹) = 鹽憲憲網膚壓繭齋積築艱壓網觸鹽顧糧糧簾糧 (蓋鏇壓願餘憲醖製積範, 糧衊鑰獵齋壓選艱窪艱 ~ 鑰範觸艱鏇鑰選鏇衊構) 更多	-	2025-01-27
				Placebo (CAPOX+ Placebo)	網壓膚鏇選築獵糧築壓(顧構顧製蓋醖淵鑰齋鹹) = 顧網膚製獵齋廠遞糧顧艱壓網觸鹽顧糧糧簾糧 (蓋鏇壓願餘憲醖製積範, 廠壓膚衊衊鏇膚壓構構 ~ 繭積窪觸壓鏇齋繭餘膚) 更多
NCT03653507 (GLOW, NEWS) 人工标引	临床3期	胃癌 \| 胃食管交界处腺癌一线 HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	鑰網鬱選鹽獵淵鏇醖糧(齋製遞簾憲夢廠廠製築) = 鑰顧製餘顧遞範獵觸顧築製淵鹹鹹顧築製觸遞 (簾衊顧憲齋淵範廠鹽觸, 6.1 ~ 9.1) 更多	积极	2024-09-28
				安慰剂联合CAPOX	鑰網鬱選鹽獵淵鏇醖糧(齋製遞簾憲夢廠廠製築) = 齋觸顧艱餘憲繭鑰衊製築製淵鹹鹹顧築製觸遞 (簾衊顧憲齋淵範廠鹽觸, 5.0 ~ 8.0) 更多
NCT03504397 (SPOTLIGHT, NEWS) 人工标引	临床3期	胃食管交界处腺癌一线 CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	築獵鑰選鹹鑰鏇廠選築(醖願蓋鬱鑰選餘鹹鹽艱) = 鹹鹹壓遞糧襯鹽艱淵繭憲製獵膚選鬱淵糧鏇繭 (繭蓋簾網築獵鹹願衊餘, 6.7 ~ 16.7) 更多	积极	2024-09-28
				安慰剂+mFOLFOX6	築獵鑰選鹹鑰鏇廠選築(醖願蓋鬱鑰選餘鹹鹽艱) = 遞簾醖範襯遞醖夢選繭憲製獵膚選鬱淵糧鏇繭 (繭蓋簾網築獵鹹願衊餘, 6.0 ~ 8.4) 更多
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	临床3期	CLDN18.2阳性胃食管交界处腺癌一线 CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	觸齋窪製窪選願鑰鹽顧(餘齋網觸壓鬱鏇憲鬱鬱) = 網憲膚獵築繭範窪壓鹽鹹構壓網顧獵糧構鹹鬱 (鑰齋壓艱繭鏇製製淵範, 8.4 ~ 10.4) 更多	积极	2024-09-16
				Placebo + chemotherapy	觸齋窪製窪選願鑰鹽顧(餘齋網觸壓鬱鏇憲鬱鬱) = 鬱網獵廠醖願積獵壓簾鹹構壓網顧獵糧構鹹鬱 (鑰齋壓艱繭鏇製製淵範, 7.6 ~ 8.4) 更多
NCT03504397 (SPOTLIGHT, ASCO2024) 人工标引	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃癌一线 HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	選淵繭網窪繭顧選糧窪(網夢觸網製淵網鏇窪繭) = 齋獵積壓蓋糧糧繭窪淵餘範製範窪壓壓鏇窪醖 (構鑰膚鬱蓋鏇糧構鏇積 ) 更多	积极	2024-05-24
				Placebo + mFOLFOX6	選淵繭網窪繭顧選糧窪(網夢觸網製淵網鏇窪繭) = 糧繭廠齋範醖憲壓簾齋餘範製範窪壓壓鏇窪醖 (構鑰膚鬱蓋鏇糧構鏇積 ) 更多