This is a Single-center, Single-arm, Phase II, Prospective Clinical Study Planning to Enroll 30 Patients With Advanced Renal Cell Carcinoma. Eligible Patients, After Signing the Informed Consent Form and Passing the Screening Process, Will Receive Envafolimab + Axitinib Treatment Until Disease Progression or Intolerable Toxicity (Treatment Duration Not Exceeding 24 Months). Clinical Tumor Imaging Assessments Will be Conducted Every 12 Weeks During the Treatment Process According to the RECIST V1.1 Criteria. Safety Will be Assessed Using CTCAE 5.0, With Adverse Events Recorded From Each Treatme

Introduction:
This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunotherapy) and Axitinib (a targeted therapy) - for patients newly diagnosed with advanced kidney cancer (specifically, clear cell Renal Cell Carcinoma or RCC). This information is designed to help patients, their families, and healthcare providers understand the study's purpose, procedures, potential benefits and risks, and what participation involves.
1. What is the Study About?
* The Problem: Advanced kidney cancer (RCC) that has spread (metastatic) or cannot be removed by surgery (unresectable) is challenging to treat. While treatments exist, researchers are always looking for more effective and manageable options, especially for patients who haven't had prior systemic (whole-body) anti-cancer therapy.
* The New Approach: This study combines two types of drugs:
* Envafolimab: An "immunotherapy" drug given as an injection under the skin (subcutaneous). It works by blocking a protein called PD-L1 on cancer cells or immune cells. Blocking PD-L1 helps the patient's own immune system recognize and attack the cancer cells more effectively.
* Axitinib: A "targeted therapy" drug taken as a pill twice daily. It works by blocking signals (VEGF receptors) that cancer cells use to grow new blood vessels, essentially starving the tumor of its blood supply.
* The Goal: To find out if giving Envafolimab and Axitinib together is safe and effective as the first treatment for patients with advanced kidney cancer. Researchers want to see how well the combination shrinks tumors, controls the cancer, and how long patients live without their cancer getting worse, while carefully monitoring side effects.
* Study Design:
* Phase II: This is an early stage of testing in patients, focusing mainly on how well the treatment works and its safety profile in a specific group.
* Single-Arm: All participants in this study will receive the same combination treatment (Envafolimab + Axitinib). There is no separate group receiving a different treatment or placebo for comparison in this particular study.
* Single-Center: Currently being run at Peking Union Medical College Hospital (but could potentially expand).
* Participants: Plans to enroll about 30 patients.
* Treatment Duration: Patients receive treatment as long as it's working (tumor isn't growing) and they can tolerate the side effects, for up to a maximum of 2 years.
2. Key Information for Patients & Families:
* Who Might Qualify? You may be eligible to participate if you:
* Are between 18 and 75 years old.
* Have been diagnosed with advanced clear cell kidney cancer (unresectable or metastatic).
* Have NOT received any prior systemic anti-cancer treatment (like chemotherapy, immunotherapy, or other targeted therapies) for your advanced kidney cancer.
* Have tumors that can be measured on scans (CT or MRI).
* Are relatively active and able to care for yourself (ECOG performance status 0 or 1: meaning you are either fully active or restricted in physically strenuous activity but ambulatory and able to do light work).
* Have adequate organ function (healthy enough bone marrow, liver, kidneys, heart) as determined by blood tests.
* Are expected to live at least 6 more months.
* Understand the study and agree to follow the procedures and attend all visits.
* Who Would Not Qualify? You would likely not be eligible if you:
* Have another active cancer besides the kidney cancer being studied.
* Have had previous systemic treatment for your advanced kidney cancer.
* Have known severe allergies to similar drugs or components of Envafolimab/Axitinib.
* Have an active autoimmune disease needing strong medication (like high-dose steroids or immunosuppressants) within the last 2 years. (Hormone replacements like thyroid meds are okay).
* Are taking high-dose steroids (except inhaled/nasal) or other immune-suppressing drugs shortly before starting.
* Are using traditional Chinese medicine or immunomodulators within 2 weeks before joining.
* Have serious uncontrolled heart problems (like recent heart attack, severe heart failure, unstable angina, significant irregular heartbeats).
* Have uncontrolled fluid build-up needing drainage (like large amounts of ascites or pleural effusion).
* Are pregnant, breastfeeding, or unwilling to use highly effective contraception during the study and for 6 months after.
* Have significant psychiatric, substance abuse, or other medical/social issues that the research team believes would interfere with the study.

开始日期2025-09-01

申办/合作机构

北京协和医院

NCT07142863

/ Not yet recruiting临床2期IIT

Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma

Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.

开始日期2025-08-25

申办/合作机构

上海市第一人民医院

NCT06772233

/ Not yet recruiting临床2期IIT

A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment.

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

开始日期2025-07-30

申办/合作机构

北京大学

100 项与恩沃利单抗相关的临床结果

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100 项与恩沃利单抗相关的专利（医药）

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项与恩沃利单抗相关的文献（医药）

2025-10-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Subcutaneously administered anti-PD-(L)1 antibodies are predominantly absorbed via the lymphatic system, resulting in high drug exposure to draining lymph nodes

Article

作者: Fei, Xiaoxuan ; Sun, Lie ; Yan, Simin ; Li, Li ; Zou, Jianjun ; Ge, Weihong ; Hu, Luojuan ; Han, Sifei ; Zhang, Huimin ; Pei, Junyi

Compared to classic intravenous (IV) administration, subcutaneous (SC) delivery of monoclonal antibodies (mAbs) offers new opportunities to improve patient compliance and healthcare efficiency. However, insufficient understanding of drug absorption process following SC administration, particularly the role of lymphatic transport, may hinder the development of SC formulations for mAbs. The current study aimed to examine the absorption route of widely used anti-PD-(L)1 mAbs following SC injection, and four marketed products (Pembrolizumab, Tislelizumab, Envafolimab, Sugemalimab) were selected as the model drugs. In the thoracic lymph duct cannulated rat model, all mAbs were found to be primarily absorbed via the lymphatics following SC injection, with 63.1-72.0% of the administered dose recovered in the thoracic lymph, contributing to >80% of SC bioavailability. This absorption pattern also resulted in elevated exposure of mAbs in draining lymph nodes (an order of magnitude higher drug concentrations compared to the systemic drug exposure). In addition, markedly different lymphatic absorption profiles were observed following SC administration at different sites, reflecting specific draining routes associated with certain anatomical regions in the rat. Our data suggested that the food pad is likely the optimal SC injection site for quantitative studies of lymphatic transport, whereas injection to the lower hind leg (a common SC injection site in previous studies) appeared to underestimate the absolute extent of lymphatic drug transport in the thoracic lymph-duct cannulated rat model, as these sites are drained by lymphatic networks that cannot be fully captured by the thoracic lymph-duct cannulation model.

2025-09-01·JOURNAL OF CONTROLLED RELEASE

A super-long-acting anti-PD-L1 nanobody fused to elastin-like polypeptide for triple-negative breast cancer immunotherapy

Article

作者: Gao, Weiping ; Yang, Zhaoying ; Zhang, Fan ; Sun, Yuanzi ; Yao, Qiongqiong

The limited tumor penetration of monoclonal antibodies or the rapid renal clearance of nanobodies hamper their application in cancer immunotherapy. Through genetic engineering, we fuse a thermosensitive elastin-like polypeptide of ELP(V) with a nanobody of KN035 that binds specifically to human programmed cell death protein ligand 1 (PD-L1) to generate a conjugate of KN035-ELP(V) for triple-negative breast cancer (TNBC) therapy. The high affinity of KN035-ELP(V) enables it to efficiently block the interaction of PD1 and PD-L1. A single intraperitoneal administration of KN035-ELP(V) leads to the in situ generation of a sustained-release depot, showing a circulating half-life that is 276.4-fold and 5.1-fold longer than those of KN035 and KN035 fused with fragment crystallizable (KN035-Fc), respectively. Additionally, KN035-ELP(V) outperforms KN035 and KN035-Fc in term of accumulation and penetration in tumor tissue. Compared to KN035 and KN035-Fc treatments, a single injection of KN035-ELP(V) induces a durable and efficient antitumor immunity in TNBC-bearing mice, resulting in improved anti-tumor efficacy with reduced adverse effects. Therefore, KN035-ELP(V) is promising as a super-long-acting anti-PD-L1 nanobody for efficient cancer immune checkpoint blockade therapy.

2025-09-01·ONCOLOGIST

Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide

Article

作者: Ji, Feng ; Lin, Hao ; Ding, Bo ; Shen, Yang ; Xu, Jingyun ; Zhao, Xiang ; Yu, Tianxiang ; Qiu, Shanhu ; Zheng, Shiya

Abstract:

Background:

Effective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.

Methods:

This was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion who were administered envafolimab subcutaneously on day 1 and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6-10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

Of the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% (95% CI 21.5%-69.2%), and the DCR was 83.3% (95% CI 58.6%-96.4%). The median PFS was 10.2 months (95% CI 5.6-not applicable [NA]), and the median OS was 21.3 months (95% CI 6.8-NA). The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.

Conclusion:

Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.

ClinicalTrials.gov identifier:

NCT05422183

601

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2025-10-22

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康宁杰瑞制药-B（09966.HK）10月22日收盘跌2.47%，主力资金净流入232.42万港元

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抗体药物偶联物

2025-10-22

·思路迪医药 3D Medicines

2025 ESMO | 恩维达®多项研究成果闪耀亮相德国柏林

欧洲内科肿瘤学会（ESMO）作为全球最具影响力的肿瘤学盛会之一，始终致力于推动全球抗肿瘤事业的发展与进步。2025年10月17-21日（当地时间），ESMO 大会在德国柏林以线上结合线下的形式隆重召开，揭示了众多最新临床科研成果，吸引全球顶尖专家探讨肿瘤治疗与管理的前沿趋势。本次会议上，恩维达®（恩沃利单抗注射液）多项研究成果入选大会并展示。恩维达®（恩沃利单抗注射液）多领域彰显优异疗效，为患者带来新的获益与期待中文标题：恩沃利单抗联合放化疗治疗局部晚期宫颈癌：一项前瞻性、单臂、II期研究英文标题： Envafolimab and radiochemotherapy for locally advanced cervical cancer：A prospective, single-arm, phase II study 摘要号：1189P 作者：重庆大学附属肿瘤医院周琦教授等主要结果：本研究首次证实恩沃利单抗联合同步放化疗在局部晚期宫颈癌患者中具有初步疗效和可耐受的安全性。截至2025年4月20日（中位随访时间10.8个月），32例受试者接受了疗效评估，1年无进展生存率（PFS率）为94.4%。客观缓解率（ORR）达93.8%，其中14例（43.8%）达到完全缓解（CR），16例（50.0%）达到部分缓解（PR）。大部分常见不良事件（AE）为1-2级，可控且可逆。≥3级AE包括白细胞计数降低（44.4%）、中性粒细胞计数降低（25.0%）及贫血（8.3%）。参考文献：Qi Z, et al. Envafolimab and radiochemotherapy for locally advanced cervical cancer: A prospective, single-arm, phase II study. 2025 ESMO, 1189P. 中文标题：恩沃利单抗联合重组人内皮抑素和化疗作为转移性胰腺癌的一项单臂探索性II期试验英文标题： Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as First - line treatment in metastatic pancreatic cancer: A single - arm,exploratory, phase II trial 摘要号：2234P 作者：徐州医科大学附属医院韩正祥教授等主要结果：本研究旨在评估恩沃利单抗（一种皮下注射的 PD - L1 抑制剂）联合重组人内皮抑素及AG 化疗方案（吉西他滨联合白蛋白结合型紫杉醇）作为转移性胰腺癌（mPC）一线治疗的疗效与安全性。截至2025 年5 月6 日，12 例转移性胰腺癌患者可进行疗效评估，中位年龄69 岁（范围28 - 75 岁），其中男性9例，女性3 例。中位随访9.97 个月，ORR为54.54%，疾病控制率（DCR）达100%，中位无进展生存期（PFS）为8.0个月（95%CI, 6.506 - 9.494），中位总生存期（OS）尚未达到。33.3% 的患者发生≥3 级治疗相关不良事件（TRAE），最常见的有贫血（33%）、血小板减少（8.3%）、中性粒细胞减少（16.6%）和手足麻木（8.3%）。未出现新的安全性信号及治疗相关死亡事件。初步数据显示，恩沃利单抗联合Rh-内皮抑素及AG方案作为转移性胰腺癌（mPC）一线治疗方案展现出令人鼓舞的疗效和可耐受的安全性。参考文献： Zhengxiang Han, et al. Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as First - line treatment in metastatic pancreatic cancer: A single - arm,exploratory, phase II trial. 2025 ESMO, 2234P. 中文标题：新辅助恩沃利单抗联合放化疗治疗局部晚期癌症的探索性II期研究英文标题： Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II study 摘要号：783P 作者：Xu Guan，et al. 主要结果：该研究针对局部晚期直肠癌（LARC）标准新辅助放化疗病理完全缓解（pCR）率较低的现状，探索恩沃利单抗联合放化疗的疗效与安全性。研究纳入18 - 60 岁、经组织学证实为T3-4N0M0或T1-4N+M0、微卫星稳定（MSS）/ 错配修复功能正常（pMMR）的LARC 患者。符合条件的患者接受短程T放疗（25 Gy/5f），随后进行4 个周期的恩沃利单抗（300mg）联合CapeOX 方案（奥沙利铂130mg/m²；卡培他滨1000mg/m²），之后接受手术切除。在2023 年10 月18 日至2025 年1 月9 日期间，41 例患者入组并接受治疗。在完成手术的25 例（61.0%）患者中，16 例（64.0%；95% CI, 42.6 - 81.3）达到pCR，所有患者（100.0%）实现R切除，括约肌保留率为68.0%（17/25）。截至2025 年5 月8 日，无病生存期（DFS）和OS数据尚不成熟。所有患者（100.0%）均发生AE，最常见的是淋巴细胞计数降低（87.8%）和低白蛋白血症（82.9%）。16 例（39.0%）患者出现≥3 级AE，2 例（4.9%）患者出现严重AE。参考文献： Xu Guan, et al.Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II study. 2025 ESMO, 783P. 中文标题：恩沃利单抗联合放化疗治疗局部晚期鼻咽癌（NPC）的前瞻性单臂II期临床试验英文标题： Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial 摘要号：1378P 作者：中山大学王晓辉教授主要结果： 2022年6月14日至12月13日期间，中山大学肿瘤防治中心共入组36例患者（中位年龄44岁，男性占比63.9%）。截至2025年5月4日，中位随访时间为28.72个月（四分位距：28.22-29.77个月)，ORR和DCR均为97.2%（95%CI, 85.5%-99.9%）。2年无进展生存率为97.2%（95%CI, 0.92-1）。安全性方面, 就3-4级急性不良事件而言, 恩沃利单抗联合治疗方案中显著优于与标准方案, 仅3-4级贫血发生率超过10%。恩沃利单抗联合同步放化疗在局部晚期鼻咽癌治疗中表现出令人鼓舞的疗效与安全性。三年无进展生存期数据尚未成熟，需进一步随访验证。参考文献： Xiaohui Wang, et al. Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial 2025 ESMO, 1378P. 中文标题：恩沃利单抗和西达苯胺联合GEMOX作为晚期和转移性胆道癌的一线治疗（B-Enefits/SCOG-B001）：单臂、探索性II期试验英文标题： Envafolimab and Chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial 摘要号：85P 作者：苏州大学附属第一医院李伟教授等主要结果：研究是一项单臂、多中心、前瞻性II期临床试验，旨在评估恩沃利单抗与西达本胺联合吉西他滨加奥沙利铂（GEMOX）方案在胆道恶性肿瘤一线治疗的疗效与安全性。研究期间共纳入35例患者，其中胆管癌29例，胆囊癌6例。ORR和DCR分别为51.43%（18/35）和77.14%（27/35）。PFS为8.13个月（95%CI, 2.34-13.92），OS尚未达到。3-4级治TRAE发生率为68.57%，包括血小板减少（48.57%）、贫血（37.14%）、白细胞减少（37.14%）等。无治疗相关死亡病例报告。生物标志物分析显示，治疗后外周血全身免疫炎症指数显著降低，尤其在PR组患者相较于SD和PD组患者更为明显。PR组患者的循环CD45+HLA-DR+细胞、肿瘤浸润CD3+和CD8+细胞、以及基质M1极化巨噬细胞浸润均表现为增加。恩沃利单抗与西达本胺联合GEMOX的创新组合方案在晚期胆道癌患者中展现出具有临床意义的抗肿瘤活性，且毒性可控。参考文献： Wei L, et al. Envafolimab and Chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial. 2025 ESMO, 85P. 关于思路迪医药（3D Medicines Inc.）思路迪医药（1244.HK）是一家处于商业化阶段的肿瘤创新药物研发公司，自主研发多款具有全球领先或临床价值的差异化创新候选药物及疫苗产品，已建立一支研发、生产和商业化的国际化专业团队，致力于帮助肿瘤患者活得更久更好。公司现有17条管线中8款进入临床阶段，首个商业化产品恩维达®（全球首个皮下注射PD-L1单域抗体）上市四年已惠及数万患者，奠定肿瘤免疫治疗差异化优势。公司目前依托三大自主研发平台驱动创新, 包括创新的In vivo CAR-T/NK技术平台，多种自体生成CAR-T细胞的新一代产品，覆盖肿瘤、自免疾病等多元治疗场景，通过自主知识产权tLNP递送系统，突破传统体外CAR-T类产品限制，无需体外清淋，带来更安全、更具可及性的现货型免疫治疗解决方案；AI+mRNA肿瘤疫苗3D-preciseAG平台，并基于自建LNP递送系统突破专利壁垒，显著提升mRNA递送效率，降低毒性；以及核药偶联物RDC研发平台，聚焦开发具有Best-in-class潜力的放射性药物。思路迪医药坚持以患者获益为核心，通过科学创新与高效商业化并重的发展策略，持续提升产品全球竞争力，为股东创造长期价值，推动业绩可持续性增长。更多信息请访问: http://www.3d-medicines.com 思路迪医药前瞻性声明本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内所有关于或引用的本公司及董事的陈述、观点或意愿乃本文章刊发日期作出，可能因未来发展而出现变动。 ▇ 思路迪医药 | 3D Medicines

临床结果临床2期

2025-10-21

·证券之星

康宁杰瑞制药-B（09966.HK）：10月21日南向资金减持89.3万股

证券之星消息，10月21日南向资金减持89.3万股康宁杰瑞制药-B（09966.HK）。近5个交易日中，获南向资金减持的有5天，累计净减持118.6万股。近20个交易日中，获南向资金减持的有20天，累计净减持485.5万股。截至目前，南向资金持有康宁杰瑞制药-B（09966.HK）1.79亿股，占公司已发行普通股的18.36%。康宁杰瑞生物制药是一家主要从事肿瘤生物制剂研发、制造及商业化的投资控股公司。该公司高度差异化的内部管线由处于不同研发阶段的ADCs、单克隆抗体及双特异性抗体肿瘤药物组成。该公司的候选药物包括KN046（PD-L1/CTLA-4双特异性抗体）, KN026（抗HER2双特异性抗体）, KN035（皮下注射PD-L1）, JSKN003（HER2双表位ADC）等，用于1L sq NSCLC、乳腺癌 2+HER L1、晚期实体瘤、HER2表达实体瘤等适应症。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。

抗体药物偶联物

100 项与恩沃利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

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
结直肠癌	中国	四川思路康瑞药业有限公司	2021-11-24
MSI-H 实体瘤	中国	四川思路康瑞药业有限公司	2021-11-24

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
非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2023-11-27
非小细胞肺癌IIIB期	临床3期	中国	四川思路康瑞药业有限公司	2023-11-17
局部晚期直肠癌	临床3期	中国	浙江大学医学院附属邵逸夫医院（浙江省邵逸夫医院）	2023-04-01
胆管癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
胆管癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆道癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
转移性胆道癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
晚期胆道癌	临床3期	-	思路迪生物医药（上海）有限公司	-

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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


NCT05422183 (ENLEN-OC-001, Pubmed \| Oncologist)	临床2期	铂耐药性卵巢癌	18	Envafolimab + Lenvatinib + Etoposide	鏇範醖簾鏇築壓獵齋鏇(憲獵醖遞網選鬱夢窪繭) = 築衊糧鬱艱網遞衊壓範鬱鏇獵願製襯鹽繭廠窪 (鹽蓋鑰餘齋淵鬱築鏇壓, 21.5 ~ 69.2) 更多	积极	2025-09-01
NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	窪憲選淵膚網壓顧獵蓋(範鹽憲膚壓鹽鬱繭衊遞) = 願醖構觸構蓋淵觸遞繭繭餘鬱鹽憲網選顧觸簾 (鏇憲構顧鏇獵鹹淵獵遞, 15.6 ~ 55.3) 更多	积极	2025-05-30
NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	窪憲選淵膚網壓顧獵蓋(範鹽憲膚壓鹽鬱繭衊遞) = 廠窪夢襯獵淵醖網窪餘繭餘鬱鹽憲網選顧觸簾 (鏇憲構顧鏇獵鹹淵獵遞, 0.5 ~ 14.8) 更多	积极	2025-05-30
ChiCTR2100044981 (ASCO2025)	临床2期	广泛期小细胞肺癌一线	32	Envafolimab + Carboplatin + Etoposide	觸壓醖齋製繭襯襯顧壓(鏇齋繭蓋襯衊膚糧餘糧) = 夢選鏇網襯網鑰憲遞願糧艱範製鬱齋鏇襯鹽淵 (壓齋夢觸製鏇鹹築鹽窪, 4.83 ~ 7.67) 更多	积极	2025-05-30
ASCO2025	N/A	晚期恶性实体瘤 dMMR \| microsatellite instability high (MSI-H)	17	Envafolimab monotherapy	獵製鏇顧獵積醖淵醖鬱(衊餘獵艱衊鏇積齋壓願) = 製蓋襯製繭艱網糧糧選淵網淵鏇襯遞鏇淵網壓 (構願淵壓鏇顧願衊憲窪 ) 更多	积极	2025-05-30
NCT05243355 (ASCO2025)	临床2期	鳞状非小细胞肺癌一线	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	艱觸艱鬱鏇鬱繭艱繭衊(簾襯餘齋構鑰襯衊艱繭) = 餘蓋繭憲網憲淵淵簾淵艱簾淵築遞齋蓋蓋鹹築 (壓築鏇膚夢餘衊願蓋獵, 43.0% ~ 83.3%) 更多	积极	2025-05-30
NCT05910034 (ASCO2025)	临床2期	非小细胞肺癌二线 PD-1 inhibitors	25	Trilaciclib+Envafolimab+Docetaxel	淵壓醖構顧艱顧觸夢鑰(襯齋繭壓構艱繭鹹繭膚) = Hematological toxicity occurred in 17/25 (68%) pts during the first cycle, with a lower incidence in cohort A compared to cohorts B and C 衊衊淵衊範獵觸鑰糧鏇 (淵餘積淵繭構膚觸範膚 ) 更多	积极	2025-05-30
NCT05910034 (ASCO2025)	临床2期	非小细胞肺癌二线 PD-1 inhibitors	25	Docetaxel+Envafolimab		积极	2025-05-30
NCT05828381 (Phase II study, ASCO2025)	临床2期	局部晚期食管鳞状细胞癌新辅助	32	Envafolimab + Albumin-bound Paclitaxel + Cisplatin	襯構齋糧蓋憲簾構顧鏇(構醖獵鏇願壓糧憲糧鑰) = One patient occurred cerebral hemorrhage 遞夢夢齋鬱襯網鬱繭獵 (淵網製蓋鹽繭觸繭夢襯 ) 更多	积极	2025-05-30
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts who never received PD-1 or PD-L1 inhibitors before)	顧觸憲構夢構襯顧選餘(構廠觸鬱艱鹹願範選繭) = 醖淵壓壓範窪膚窪淵蓋夢鑰艱遞積範鹹憲構夢 (鏇夢憲鹹網觸積製憲範 ) 更多	积极	2025-01-23
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts have failed first-line PD-1 antibody combined chemotherapy, with optimal efficacy as or above stable disease)	顧觸憲構夢構襯顧選餘(構廠觸鬱艱鹹願範選繭) = 廠廠鹽顧夢夢簾網鹹襯夢鑰艱遞積範鹹憲構夢 (鏇夢憲鹹網觸積製憲範 ) 更多	积极	2025-01-23
NCT05529355 (ESMO_ASIA2024) 人工标引	临床2期	非小细胞肺癌末线 \| 二线	20	Envafolimab 150mg + Chemotherapy/Anti-VEGF	鬱繭廠構選壓鑰蓋蓋築(夢網製網鬱艱糧顧築願) = 積選遞餘淵膚選鑰糧鹽艱簾構廠醖網淵積餘範 (淵餘鹽願衊淵遞憲鑰鹽 ) 更多	积极	2024-12-07
ChiCTR2200055407 (Pubmed)	临床2期	肝细胞癌一线	36	仑伐替尼+恩沃利单抗	簾願鹹鑰夢鹹鹽膚簾觸(衊襯觸觸糧願鑰鹽糧鏇) = 顧網憲艱醖淵築獵遞獵遞願鹹膚夢遞襯積醖餘 (醖製鏇齋選淵衊窪艱網 ) 更多	积极	2024-12-01