Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial

Rocconi Rodney P.; Grosen Elizabeth A.; Ghamande Sharad A.; Chan John K.; Barve Minal A.; Oh Jonathan; Tewari Devansu; Morris Peter C.; Stevens Erin E.; Bottsford-Miiler Justin N.; Tang Min; Aaron Phylicia; Stanbery Laura; Horvath Staci; Wallraven Gladice; Bognar Ernest; Manning Luisa; Nemunaitis John; Shanahan David; Slomovitz Brian M.; Herzog Thomas J.; Monk Bradley J.; Coleman Robert L.

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Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial

机译：GemogenovaTucel-T（vigil）免疫疗法在前线阶段III / IV卵巢癌中的维护（至关重要）：随机，双盲，安慰剂控制，第2B期试验

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Background Gemogenovatucel-T is an autologous tumour cell vaccine manufactured from harvested tumour tissue, which specifically reduces expression of furin and downstream TGF-beta 1 and TGF-beta 2. The aim of this study was to determine the safety and efficacy of gemogenovatucel-T in front-line ovarian cancer maintenance.

机译：背景Gemogenovatucel-T是一种从采集的肿瘤组织中制备的自体肿瘤细胞疫苗，可特异性降低furin及其下游TGFβ1和TGFβ2的表达。本研究的目的是确定gemogenovatucel-T在卵巢癌一线维护中的安全性和有效性。

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《The lancet oncology》 |2020年第12期|共12页
作者
Rocconi Rodney P.; Grosen Elizabeth A.; Ghamande Sharad A.; Chan John K.; Barve Minal A.; Oh Jonathan; Tewari Devansu; Morris Peter C.; Stevens Erin E.; Bottsford-Miiler Justin N.; Tang Min; Aaron Phylicia; Stanbery Laura; Horvath Staci; Wallraven Gladice; Bognar Ernest; Manning Luisa; Nemunaitis John; Shanahan David; Slomovitz Brian M.; Herzog Thomas J.; Monk Bradley J.; Coleman Robert L.;
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作者单位

Univ S Alabama Mitchell Canc Inst Div Gynecol Oncol Mobile AL USA;

Canc Care Northwest Dept Obstet &

Gynecol Spokane WA USA;

Augusta Univ Sect Gynecol Oncol Augusta GA USA;

Calif Pacific Palo Alto Med Fdn Sutter Ctr Res Inst Div Gynecol Oncol San Francisco CA USA;

Mary Crowley Canc Res Ctr Dept Oncol Dallas TX USA;

Texas Oncol Dept Oncol Dallas TX USA;

Kaiser Permanente Dept Obstet &

Gynecol Irvine CA USA;

Nebraska Methodist Hosp Div Gynecol Oncol Omaha NE USA;

Billings Clin Dept Gynecol Oncol Billings MT USA;

Billings Clin Dept Gynecol Oncol Billings MT USA;

StatBeyond Consulting Stats Dept Irvine CA USA;

Gradalis Dept Med Affairs Carollton TX 75006 USA;

Gradalis Dept Med Affairs Carollton TX 75006 USA;

Gradalis Dept Site Res Carollton TX USA;

Gradalis Dept Clin &

Regulatory Operat Carollton TX USA;

Gradalis Dept CMC Operat Carollton TX USA;

Gradalis Dept Med Affairs Carollton TX 75006 USA;

Gradalis Dept Med Affairs Carollton TX 75006 USA;

Gradalis Management Dept Carollton TX USA;

Broward Hlth Dept Obstet &

Gynecol Ft Lauderdale FL USA;

Univ Cincinnati Canc Ctr Dept Obstet &

Gynecol Cincinnati OH USA;

Arizona Oncol Dept Obstet &

Gynecol Phoenix AZ USA;

US Oncol Res The Woodlands TX USA;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学;
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1. Gemogenovatucel-T (Vigil) Immunotherapy as Maintenance in Frontline Stage III/IV Ovarian Cancer (VITAL): A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial [J] . Van Le Linda Obstetrical and gynecological survey . 2021,第3期

机译：GemogenovaTucel-T（vigil）免疫疗法在前线阶段III / IV卵巢癌中的维护（至关重要）：随机，双盲，安慰剂控制，第2B期试验
2. RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF FRONTLINE MAINTENANCE VIGIL IMMUNOTHERAPY (VITAL STUDY) IN STAGE III/IV OVARIAN CANCER: EFFICACY ASSESSMENT IN BRCA1/2-WT PATIENTS [J] . Rocconi R., Grosen E., Ghamande S., International journal of gynecological cancer: official journal of the International Gynecological Cancer Society . 2020,第Suppla3期

机译：III阶段/ IV卵巢癌中的前线维持免疫治疗（重要研究）的随机双盲安慰剂对照试验：BRCA1 / 2-WT患者的疗效评估
3. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial [J] . Quoix Elisabeth, Lena Herve, Losonczy Gyorgy, The lancet oncology . 2016,第2期

机译：TG4010用于晚期非小细胞肺癌（TIME）的免疫疗法和一线化疗：来自随机，双盲，安慰剂对照，2b / 3期试验的2b期结果
4. Effects of laser immunotherapy on late-stage, metastatic breast cancer patients in a Phase Ⅱ clinical trial [C] . Gabriela L. Ferrel, Feifan Zhou, Xiaosong Li, Biophotonics and immune responses IX . 2014

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5. Maintenance Sunitinib following Initial Platinum-Based Combination Chemotherapy in Advanced-Stage IIIB/IV Non–Small Cell Lung Cancer: A Randomized Double-Blind Placebo-Controlled Phase III Study—CALGB 30607 (Alliance) [O] . Maria Q. Baggstrom, Mark A. Socinski, Xiaofei F. Wang, -1

机译：晚期IIIB / IV期非小细胞肺癌初始铂类联合化疗后的维持舒尼替尼：一项随机双盲安慰剂对照的III期研究—CALGB 30607（联盟）
6. The ACT-ONE trial, a multicentre, randomised, double-blind, placebo-controlled, dose-finding study of the anabolic/catabolic transforming agent, MT-102 in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer: [O] . Andrew J. Stewart Coats, Venkatesan Srinivasan, Jayaraman Surendran, 2011

机译：ACT-ONE试验是同化/分解代谢转化剂MT-102在与III和IV期非小细胞肺癌相关的恶病质患者中进行的多中心，随机，双盲，安慰剂对照，剂量寻找研究和大肠癌：

Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial

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