Abstract：
Due to the widespread use of cancer genetic testing in gastrointestinal cancer, the BRCA1/2 genetic mutation has been identified in biliary tract cancer as well as pancreatic cancer. Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor, and PARP inhibitors exert their cytotoxicity against cancer cells in the context of homologous recombination deficiency, such as BRCA mutations, via the mechanism of synthetic lethality. The aim of this phase II NIR-B trial is to evaluate the efficacy and safety of niraparib for patients with unresectable advanced or recurrent biliary tract cancer, pancreatic cancer or other gastrointestinal cancers with germline or somatic BRCA1/2 mutations revealed by genetic testing. The primary end point is an investigator-assessed objective response rate in each cohort.Clinical Trial Registration: jRCT2011200023 (ClinicalTrials.gov).
A clinical study to confirm the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with the BRCA genetic mutation: the NIR-B trial.BRCA gene is involved in repairing DNA injury and plays an important role in cancer growth. Cells with a mutation in the BRCA gene cannot repair DNA using a method called homologous recombination repair. Niraparib is part of a class of drugs called ‘PARP inhibitors’ that inhibit enzymes called ‘PARP’ involved in repairing DNA injury, and has shown efficacy against cancers with BRCA gene mutations. BRCA gene mutations are infrequent but have been found in a variety of cancers. The NIR-B trial is a clinical trial to evaluate the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with BRCA gene mutations.
A clinical study to confirm the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with the BRCA genetic mutation: the NIR-B trial.BRCA gene is involved in repairing DNA injury and plays an important role in cancer growth. Cells with a mutation in the BRCA gene cannot repair DNA using a method called homologous recombination repair. Niraparib is part of a class of drugs called ‘PARP inhibitors’ that inhibit enzymes called ‘PARP’ involved in repairing DNA injury, and has shown efficacy against cancers with BRCA gene mutations. BRCA gene mutations are infrequent but have been found in a variety of cancers. The NIR-B trial is a clinical trial to evaluate the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with BRCA gene mutations.
摘要：
由于癌症基因检测在胃肠道肿瘤中的广泛应用，BRCA1/2基因突变已在胆道癌和胰腺癌中被发现.Niraparib是一种聚（ADP-核糖）聚合酶（PARP）抑制剂，PARP抑制剂在同源重组缺陷的情况下对癌细胞发挥细胞毒性，如BRCA突变，通过合成致死机制。这项II期NIR-B试验的目的是评估尼拉帕尼治疗不可切除的晚期或复发性胆道癌患者的疗效和安全性。通过基因检测发现的具有种系或体细胞BRCA1/2突变的胰腺癌或其他胃肠道癌症。主要终点是每个队列中研究者评估的客观缓解率。临床试验注册：jRCT2011200023（ClinicalTrials.gov）。
BRCA基因参与DNA损伤的修复，在肿瘤生长中起重要作用。BRCA基因突变的细胞无法使用称为同源重组修复的方法修复DNA。Niraparib是一类称为“PARP抑制剂”的药物的一部分，该药物抑制与修复DNA损伤有关的称为“PARP”的酶，并已显示出对具有BRCA基因突变的癌症的功效。BRCA基因突变很少见，但已在多种癌症中发现。NIR-B试验是一项临床试验，旨在评估尼拉帕尼对晚期胆道患者的疗效和安全性，与BRCA基因突变的胰腺癌和其他腹部癌症。
BRCA基因参与DNA损伤的修复，在肿瘤生长中起重要作用。BRCA基因突变的细胞无法使用称为同源重组修复的方法修复DNA。Niraparib是一类称为“PARP抑制剂”的药物的一部分，该药物抑制与修复DNA损伤有关的称为“PARP”的酶，并已显示出对具有BRCA基因突变的癌症的功效。BRCA基因突变很少见，但已在多种癌症中发现。NIR-B试验是一项临床试验，旨在评估尼拉帕尼对晚期胆道患者的疗效和安全性，与BRCA基因突变的胰腺癌和其他腹部癌症。
