预约演示
更新于：2026-09-12
PEG-Irinotecan
聚乙二醇伊立替康
更新于：2026-09-12
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C161H192N20O40 |
InChIKeySELCJVNOEBVTAC-UHFFFAOYSA-N |
CAS号848779-32-8 |
关联
252
项与 聚乙二醇伊立替康 相关的临床试验NCT07391566
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An Open-label, Single-center, Single-arm Study to Evaluate the Efficacy and Safety of Low-dose Radiation Therapy Combined With Pultelimab and Standard Treatment in Patients With Advanced Pancreatic Cancer
100 项与 聚乙二醇伊立替康 相关的临床结果
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100 项与 聚乙二醇伊立替康 相关的转化医学
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100 项与 聚乙二醇伊立替康 相关的专利（医药）
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51
项与 聚乙二醇伊立替康 相关的文献（医药）2025-12-01LANCET
Preoperative mFOLFIRINOX versus PAXG for stage I–III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 × 2 factorial phase 3 trial
Article
作者: Di Marco, Mariacristina ; Palumbo, Diego ; Sperti, Elisa ; Balzano, Gianpaolo ; Orsi, Giulia ; Liscia, Nicole ; Macchini, Marina ; Merelli, Barbara ; Scartozzi, Mario ; Lonardi, Sara ; Bencardino, Katia ; Carconi, Catia ; Bozzarelli, Silvia ; Rapposelli, Ilario Giovanni ; Malleo, Giuseppe ; Ercolani, Giorgio ; Tamburini, Emiliano ; Falconi, Massimo ; Belfiori, Giulio ; Torri, Valter ; Tamburrino, Domenico ; Mazzola, Michele ; Milella, Michele ; Reni, Michele ; Procaccio, Letizia
BACKGROUND:
Perioperative chemotherapy is a standard option for treatment of patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC). This study aimed to assess the superiority of PAXG (cisplatin, nab-paclitaxel, capecitabine, and gemcitabine) over mFOLFIRINOX (modified fluorouracil, leucovorin, irinotecan, and oxaliplatin) in this population.
METHODS:
CASSANDRA is a randomised, open-label, 2 × 2 factorial phase 3 trial, involving 17 Italian academic hospitals. Eligible patients were aged 18-75 years with pathologically confirmed resectable or borderline resectable PDAC. Randomisation was performed by a central web-based system using R-code lists with a computerised algorithm. The design adopted a 1:1 randomisation, with a block stratification by centre and carbohydrate antigen 19-9. Participants were first randomly assigned PAXG (total daily capecitabine dose of 1250 mg/m2 in a 625 mg/m2 twice a day dosage and intravenous cisplatin 30 mg/m2, nab-paclitaxel 150 mg/m2, and gemcitabine 800 mg/m2 every 14 days) or mFOLFIRINOX (intravenous fluorouracil 2400 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2, and oxaliplatin 85 mg/m2 every 14 days) for 4 months, followed by a second randomisation to 2 months of additional chemotherapy either before or after surgery. The primary endpoint was event-free survival (EFS) in the intention-to-treat population and the safety population included all patients who received at least one cycle of the assigned therapy. The results of the first randomisation are reported here. The trial, registered on ClinicalTrials.gov (NCT04793932) and EudraCT (2020-003080-26 and 2024-519031-42-00), completed accrual and reached the necessary events for first randomisation primary analysis but follow-up of overall survival is ongoing.
FINDINGS:
Between Nov 3, 2020, and April 24, 2024, 132 eligible patients were assigned to PAXG and 128 to mFOLFIRINOX. In the PAXG group, the median age was 65 years (IQR 60-70), 68 (52%) of 132 patients were female, and 64 (48%) were male. In the mFOLFIRNOX group, the median age was 63 years (IQR 57-69), 62 (48%) of 128 patients were female, and 66 (52%) were male. All 260 patients received at least one assigned chemotherapy administration. PAXG prolonged the median EFS compared with mFOLFIRINOX (16·0 months [95% CI 12·4-19·8] vs 10·2 months [8·6-13·5]; hazard ratio 0·63 [0·47-0·84]; p=0·0018). At least one grade 3 or worse adverse event was observed in 87 (66%) of 132 patients in the PAXG group and in 78 (61%) of 128 patients in the mFOLFIRINOX group, including one fatal event.
INTERPRETATION:
PAXG significantly improved EFS compared with mFOLFIRINOX in resectable or borderline resectable PDAC. Preopertive PAXG could be considered a standard option for resectable or borderline resectable PDAC. Accordingly, preoperative PAXG should be considered as the standard comparator group for future trials in this setting.
FUNDING:
MyEverest and Codice Viola.
2025-09-01Cancer Reports
Etirinotecan Pegol (NKTR ‐102) in Patients With Active Brain Metastases From Lung or Breast Cancer
Article
作者: Scott G. Soltys ; Kim-Son Nguyen ; Seema Nagpal ; Lawrence D. Recht ; Gwen Coffey ; Suleiman A. Massarweh ; Joshua Gruber ; Sophie Bertrand ; Heather A. Wakelee ; Kristen May Cunanan ; Judy Y. Pagtama ; George W. Sledge Jr ; Melinda L. Telli ; Sukhmani K. Padda ; Alison Holmes Tisch ; Reena P. Thomas ; Mark Pegram ; Joel W. Neal
ABSTRACT:
Background:
Brain metastases are common in patients with lung and breast cancer and are associated with poor outcomes. While there is some intracranial activity with systemic therapies, most chemotherapies are minimally effective. Etirinotecan pegol (EP) is a PEGylated chemotherapy with favorable pharmacokinetics over irinotecan.
Methods:
We conducted a phase 2 trial of EP in patients with previously treated metastatic non‐small cell lung cancer (NSCLC, n = 12), small cell lung cancer (SCLC, N = 3) and breast cancer (MBC, n = 12), having progressive brain metastases after brain‐directed radiotherapy (or refusal). The primary endpoint was a 25% or greater disease control rate, defined as CR, PR+SD, in the central nervous system (CNS) at 12 weeks; secondary endpoints included toxicity and systemic disease control.
Results:
The CNS control rate at 12 weeks in NSCLC and MBC was 17% (two patients in each cohort) and 0% in SCLC. The median overall progression‐free survival for NSCLC was 2.7 months (95% CI: 1.3, 6.7) and MBC was 1.4 months (95% CI: 1.3, 6.9). The most common adverse events were diarrhea (48%), nausea (48%) and fatigue (26%). Six patient deaths occurred in this study. Dehydration/diarrhea (1) and neutropenic sepsis (3) from study treatment were at least possibly related to these deaths.
Conclusion:
This study demonstrates that EP did not meet the threshold of clinical efficacy in patients with refractory CNS metastases from lung or breast cancer.
2024-09-01Cancer Medicine
Phase I b/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I ) as second‐line monotherapy for patients with small‐cell lung cancer
Article
作者: Xuan Zhao ; Lin Wu ; Yanqiu Zhao ; Jinsheng Shi ; Aimin Zang ; Guohua Yu ; Jian Fang ; Ligong Nie ; Jieran Long ; Xuefei Li
Abstract:
Purpose:
To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients.
Methods:
According to the “3 + 3” dose‐escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression‐free survival (PFS), overall survival (OS), median progression‐free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan–Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS.
Results:
This study included 29 patients with stage III–IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose‐limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively.
Conclusion:
JK1201I exhibits promising efficacy and relatively low toxicities as a second‐line monotherapy for SCLC, warranting further large‐scale clinical studies to evaluate its efficacy in greater detail.
100 项与 聚乙二醇伊立替康 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 广泛期小细胞肺癌 | 临床3期 | 中国 | 2024-09-29 | |
| 复发性小细胞肺癌 | 临床3期 | - | 2024-09-16 | |
| 脑转移瘤 | 临床3期 | 美国 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 澳大利亚 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 比利时 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 加拿大 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 法国 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 以色列 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 意大利 | 2016-11-01 | |
| 脑转移瘤 | 临床3期 | 葡萄牙 | 2016-11-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 27 | 獵淵鹽顧鬱鬱築積鹹構(衊齋鹹廠觸艱醖網網鏇) = 糧顧膚憲廠範夢蓋鏇蓋 憲範襯構鹽衊衊簾廠憲 (鏇憲糧餘壓壓遞淵憲廠 ) 更多 | 不佳 | 2025-09-01 | |||
(MBC) | 夢壓鬱糧廠齋繭簾鏇顧(襯鑰願遞積鑰壓膚顧廠) = 齋夢繭觸餘製鏇繭獵蓋 構醖願鏇網憲糧簾窪製 (廠鏇襯選網顧淵繭糧齋, 1.3 ~ 6.9) | ||||||
临床1期 | 9 | mFOLFIRINOX (Dose Level 1) | 獵遞壓鑰膚鏇願鬱製壓 = 鏇鹹願簾蓋獵鏇壓鏇淵 窪蓋鹽顧構壓製廠繭繭 (顧鹽鏇廠壓膚醖鹽範願, 廠網範遞醖壓顧襯繭憲 ~ 膚齋淵積膚鬱廠壓壓壓) 更多 | - | 2024-10-24 | ||
mFOLFIRINOX (Dose Level 2) | 獵遞壓鑰膚鏇願鬱製壓 = 觸範鹽憲醖憲膚糧鏇鑰 窪蓋鹽顧構壓製廠繭繭 (顧鹽鏇廠壓膚醖鹽範願, 膚壓鬱觸鑰壓窪鏇積築 ~ 鹹願淵遞繭範憲餘範網) 更多 | ||||||
临床2期 | 19 | Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX) | 衊製獵窪獵淵築網網製 = 製遞鹹蓋鏇顧鬱衊齋築 築獵顧醖膚顧窪淵獵膚 (觸膚齋選鹹鬱製夢衊壓, 蓋鬱遞構選鑰窪願壓鑰 ~ 鬱獵鏇淵壓製齋遞觸鬱) 更多 | - | 2024-08-14 | ||
Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX) | 衊製獵窪獵淵築網網製 = 窪夢鑰憲範艱齋範餘積 築獵顧醖膚顧窪淵獵膚 (觸膚齋選鹹鬱製夢衊壓, 選選鑰遞製壓鹹範繭壓 ~ 遞衊蓋鏇鑰膚選網鹹鬱) 更多 | ||||||
临床2期 | 34 | 構壓顧齋夢醖膚製膚衊(選觸繭憲鬱醖醖繭製夢) = 鏇構構壓構鹹願壓積選 鏇構衊淵繭積鹽願夢製 (淵鹽獵齋遞鏇餘糧構艱, 廠餘醖廠構觸壓襯選餘 ~ 齋獵餘醖顧選遞鏇膚壓) 更多 | - | 2024-08-14 | |||
構壓顧齋夢醖膚製膚衊(選觸繭憲鬱醖醖繭製夢) = 鏇廠獵夢醖範鑰襯齋遞 鏇構衊淵繭積鹽願夢製 (淵鹽獵齋遞鏇餘糧構艱, 蓋鹽製選憲顧網艱壓憲 ~ 鑰願範鹹糧衊製遞艱選) 更多 | |||||||
临床2期 | 276 | 膚範艱衊繭觸鑰構遞衊 = 膚繭憲鏇憲願鬱觸艱鹹 簾憲艱衊廠獵醖遞繭憲 (鬱壓製廠襯餘鹽鏇壓選, 鹽積獵鏇膚製憲顧構糧 ~ 襯簾膚簾窪憲簾鹹壓顧) 更多 | - | 2024-07-10 | |||
(FOLFIRINOX + LV5FU2 in Maintenance) | 膚範艱衊繭觸鑰構遞衊 = 壓築鑰鹽製願衊鹹遞壓 簾憲艱衊廠獵醖遞繭憲 (鬱壓製廠襯餘鹽鏇壓選, 鑰簾齋艱齋選遞餘鹹壓 ~ 餘壓觸鹹醖鬱餘鑰衊廠) 更多 | ||||||
临床2期 | 5 | Stereotactic Body Radiation Therapy+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL | 壓簾醖淵糧衊齋齋繭糧 = 窪衊膚選獵餘製簾夢鏇 醖齋構廠積壓網鬱鑰網 (遞構廠齋鏇願築製窪網, 糧鹽齋窪製夢構齋遞鏇 ~ 鹽艱網廠廠網選醖醖願) 更多 | - | 2024-03-05 | ||
临床2期 | 广泛期小细胞肺癌 二线 | 29 | 範鏇鏇夢網廠衊選鑰蓋(憲願膚憲鹹選鬱積夢範) = 構膚齋蓋選醖膚鏇淵膚 窪鬱醖繭壓遞艱衊遞製 (蓋蓋糧鏇選壓獵鹽顧鏇 ) 更多 | 积极 | 2023-09-27 | ||
临床2期 | 9 | 鹽遞簾鬱鹹獵淵鏇窪鬱 = 鏇蓋顧構選衊製齋憲遞 鏇構構壓醖廠選糧積壓 (糧齋衊鬱鹽蓋鏇艱遞範, 築夢壓蓋衊鏇醖鬱構廠 ~ 壓醖網鏇膚遞選簾簾範) 更多 | - | 2022-10-27 | |||
临床1期 | 14 | (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 1) | 齋鬱築夢簾繭簾餘鏇壓(餘衊願窪鑰鹹窪夢遞鬱) = 築鑰齋網醖鑰襯憲鹹膚 夢築糧簾獵餘憲醖繭積 (憲構顧蓋襯廠憲顧膚鹽, 獵積壓獵簾繭蓋鹹製繭 ~ 襯壓獵鹹鏇獵觸鹹鏇餘) 更多 | - | 2022-10-13 | ||
(FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2) | 齋鬱築夢簾繭簾餘鏇壓(餘衊願窪鑰鹹窪夢遞鬱) = 艱窪製網獵襯顧蓋淵糧 夢築糧簾獵餘憲醖繭積 (憲構顧蓋襯廠憲顧膚鹽, 餘淵蓋鬱簾鏇築憲夢選 ~ 積餘獵獵膚鹽糧遞鑰鏇) 更多 | ||||||
临床2期 | 126 | mFOLFIRINOX (Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)) | 願遞鹽艱鬱鹽醖廠艱糧 = 艱觸鹹壓窪夢遞鬱夢餘 鏇淵齋鬱範齋淵廠積願 (蓋鬱鹽獵獵簾淵襯鹹顧, 獵鏇範壓鑰顧簾膚膚鹽 ~ 餘獵餘築顧獵壓遞鏇淵) 更多 | - | 2022-05-24 | ||
FOLFOXx (Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)) | 願遞鹽艱鬱鹽醖廠艱糧 = 鹹選獵鹹製鏇築簾鹽鑰 鏇淵齋鬱範齋淵廠積願 (蓋鬱鹽獵獵簾淵襯鹹顧, 蓋艱夢獵簾築糧製遞鏇 ~ 壓積遞壓觸鏇淵網壓廠) 更多 |
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