胃癌疫苗的临床试验
发布于 2003-12-26 · 浏览 964 · IP 上海上海
这个帖子发布于 21 年零 150 天前，其中的信息可能已发生改变或有所发展。
Phase I trial of vaccination with autologous tumor-derived gp96 (oncophage) in patients after surgery for gastric cancer
Year: 2002
Abstract No: 117 Category: Tumor Vaccines
Author(s): Christian Hertkorn, Anton Lehr, Thomas Woelfel, T. Junginger, Wolfgang G Dippold, Peter R Galle, Helga Bernhard, Jonathan J Lewis, Pramod K Srivastava, Michael Heike, Johannes Gutenberg-University-Hospital, Mainz, Germany; St. Vinzenz Hospital, Mainz, Germany; Technical University, Munich, Germany; Antigenics LLC, New York, NY.
Abstract: Tumor-derived heat shock proteins like gp96 elicit specific anti-tumor immunity in mice. The objectives of this phase I study were to evaluate the feasibility of autologous gp96 tumor vaccine preparation from gastric carcinoma tissue, to evaluate the safety and tolerability of the vaccine in patients after surgery for gastric cancer, and to study its capacity to induce a systemic anti-tumor immune response. Twenty-one patients with gastric carcinoma underwent surgery with curative intent. At least 1.5 grams of resected tumor were procured for gp96 purification. After recovery from surgery patients were vaccinated i.d. four to nine times at weekly intervals with one of 4 different dose levels (2.5, 15, 25 or 100 μg respectively) depending on the yield of gp96. Vaccine preparation was successful in 18 of 21 patients. 15 patients, 4 stage II, 4 stage IIIa, 3 stage IIIb, 4 stage IV, 14 R0-resected, 1 R1-resected, were vaccinated. 3 were not eligible because of tumor recurrence before vaccination. No toxicity or autoimmunity was observed during and after vaccination. After a median follow-up of 32 months from surgery 3 patients remain disease-free. 12 patients, 10 with stage III/IV, had tumor recurrence. The median disease free and overall survival of the 15 vaccinated patients was 7 months and 16+ months, respectively, with 9/15 patients still alive. Immune monitoring showed an expansion of CD8+CD45RO+ memory T cells in 8 of 11 and an expansion of CD8+ T cells with specific TCR-V-beta-subtypes in 2 of 9 evaluated patients. Vaccination with autologous tumor-derived gp96 in patients with gastric carcinoma is feasible, safe and well tolerated. A systemic memory T cell immune response is induced in a subset of patients by the vaccine.
题目：应用自身肿瘤衍化的gp96（oncophage）接种胃癌术后患者的I 期临床试验
作者：略。
摘要：肿瘤衍化的热休克蛋白如gp96可以引起小鼠的特异抗肿瘤免疫。本I 期临床试验的目的是评价从胃癌组织中制备自体gp96肿瘤疫苗的可行性；评价该疫苗的安全性和耐受性；研究其诱导系统抗肿瘤免疫反应的能力。21例接受治愈性手术的胃癌患者入组。至少1.5克瘤组织用来纯化gp96。患者在手术恢复后，根据gp96的获取量，选取4个剂量级 (分别为2.5, 15, 25或100 μg）中的一个，皮下接种4到9次，间隔一周。有18例患者成功获得疫苗。15例患者（4例II期，4例IIIa期, 3例 IIIb期, 4例 IV期, 14 R0切除, 1例 R1切除 ）接受了接种。3例由于接种前出现复发而未入选。接种前后未发现相关毒性和自身免疫反应。手术后中位随访32个月，3例患者无病生存。12例患者中的10例（III/IV期）出现复发。15例接种患者的中位无病期和总体生存期分别为7个月和大于16个月。15例中的9例仍然存活。免疫检测示11例可评价患者中有8例的CD8+，CD45RO+ 记忆T细胞增高；9例可评价患者中2例的特异TCR-V-β亚型 CD8+T细胞增高。胃癌患者接种自身肿瘤衍化的gp96是安全可行且能为患者耐受的。疫苗可以在一些亚组患者中诱导系统性的记忆T细胞免疫反应。
Year: 2002
Abstract No: 117 Category: Tumor Vaccines
Author(s): Christian Hertkorn, Anton Lehr, Thomas Woelfel, T. Junginger, Wolfgang G Dippold, Peter R Galle, Helga Bernhard, Jonathan J Lewis, Pramod K Srivastava, Michael Heike, Johannes Gutenberg-University-Hospital, Mainz, Germany; St. Vinzenz Hospital, Mainz, Germany; Technical University, Munich, Germany; Antigenics LLC, New York, NY.
Abstract: Tumor-derived heat shock proteins like gp96 elicit specific anti-tumor immunity in mice. The objectives of this phase I study were to evaluate the feasibility of autologous gp96 tumor vaccine preparation from gastric carcinoma tissue, to evaluate the safety and tolerability of the vaccine in patients after surgery for gastric cancer, and to study its capacity to induce a systemic anti-tumor immune response. Twenty-one patients with gastric carcinoma underwent surgery with curative intent. At least 1.5 grams of resected tumor were procured for gp96 purification. After recovery from surgery patients were vaccinated i.d. four to nine times at weekly intervals with one of 4 different dose levels (2.5, 15, 25 or 100 μg respectively) depending on the yield of gp96. Vaccine preparation was successful in 18 of 21 patients. 15 patients, 4 stage II, 4 stage IIIa, 3 stage IIIb, 4 stage IV, 14 R0-resected, 1 R1-resected, were vaccinated. 3 were not eligible because of tumor recurrence before vaccination. No toxicity or autoimmunity was observed during and after vaccination. After a median follow-up of 32 months from surgery 3 patients remain disease-free. 12 patients, 10 with stage III/IV, had tumor recurrence. The median disease free and overall survival of the 15 vaccinated patients was 7 months and 16+ months, respectively, with 9/15 patients still alive. Immune monitoring showed an expansion of CD8+CD45RO+ memory T cells in 8 of 11 and an expansion of CD8+ T cells with specific TCR-V-beta-subtypes in 2 of 9 evaluated patients. Vaccination with autologous tumor-derived gp96 in patients with gastric carcinoma is feasible, safe and well tolerated. A systemic memory T cell immune response is induced in a subset of patients by the vaccine.
题目：应用自身肿瘤衍化的gp96（oncophage）接种胃癌术后患者的I 期临床试验
作者：略。
摘要：肿瘤衍化的热休克蛋白如gp96可以引起小鼠的特异抗肿瘤免疫。本I 期临床试验的目的是评价从胃癌组织中制备自体gp96肿瘤疫苗的可行性；评价该疫苗的安全性和耐受性；研究其诱导系统抗肿瘤免疫反应的能力。21例接受治愈性手术的胃癌患者入组。至少1.5克瘤组织用来纯化gp96。患者在手术恢复后，根据gp96的获取量，选取4个剂量级 (分别为2.5, 15, 25或100 μg）中的一个，皮下接种4到9次，间隔一周。有18例患者成功获得疫苗。15例患者（4例II期，4例IIIa期, 3例 IIIb期, 4例 IV期, 14 R0切除, 1例 R1切除 ）接受了接种。3例由于接种前出现复发而未入选。接种前后未发现相关毒性和自身免疫反应。手术后中位随访32个月，3例患者无病生存。12例患者中的10例（III/IV期）出现复发。15例接种患者的中位无病期和总体生存期分别为7个月和大于16个月。15例中的9例仍然存活。免疫检测示11例可评价患者中有8例的CD8+，CD45RO+ 记忆T细胞增高；9例可评价患者中2例的特异TCR-V-β亚型 CD8+T细胞增高。胃癌患者接种自身肿瘤衍化的gp96是安全可行且能为患者耐受的。疫苗可以在一些亚组患者中诱导系统性的记忆T细胞免疫反应。
最后编辑于 2022-10-09 · 浏览 964
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