|
MechanismCSF-2R stimulants |
|
|
|
|
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ RecruitingNot Applicable 既往接受“重组人GM-CSF溶瘤Ⅱ型单纯疱疹病毒(OH2)注射液(Vero细胞)”治疗受试者的长期随访研究
[Translation] Long-term follow-up study of subjects who have previously received “recombinant human GM-CSF oncolytic herpes simplex virus type 2 (OH2) injection (Vero cells)”
1.评估接受过至少1次OH2注射液治疗受试者的迟发性不良反应和长期安全性
2.评估接受过OH2注射液治疗受试者随时间变化的长期疗效
3.评估接受过OH2注射液治疗受试者的生活质量(EORTC QLQ-C30 (version 3))
[Translation] 1. Evaluate the delayed adverse reactions and long-term safety of subjects who have received at least one OH2 injection
2. Evaluate the long-term efficacy of subjects who have received OH2 injection over time
3. Evaluate the quality of life of subjects who have received OH2 injection (EORTC QLQ-C30 (version 3))
重组人GM-CSF溶瘤Ⅱ型单纯疱疹病毒(OH2)注射液(Vero细胞)联合研究者选择的化疗(可选择增加联合或不联合免疫治疗)经至少一线标准治疗失败的不可切除的晚期或转移性胆道癌的Ⅱ期临床研究
[Translation] A phase II clinical study of recombinant human GM-CSF oncolytic herpes simplex virus type 2 (OH2) injection (Vero cells) combined with chemotherapy of the investigator's choice (with or without immunotherapy) for unresectable advanced or metastatic biliary tract cancer that has failed at least one line of standard treatment
评价瘤内注射OH2注射液联合研究者选择的化疗(可选择增加联合或不联合免疫治疗)经至少一线标准治疗失败的不可切除的晚期或转移性胆道癌受试者的有效性。
[Translation] To evaluate the effectiveness of intratumoral OH2 injection combined with investigator-selected chemotherapy (with or without the option of adding immunotherapy) in subjects with unresectable advanced or metastatic biliary tract cancer who have failed at least one line of standard therapy.
重组人GM-CSF溶瘤II型单纯疱疹病毒(OH2)注射液(Vero细胞)治疗晚期实体瘤的I/II期临床研究
[Translation] Phase I/II clinical study of recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection (Vero cells) in the treatment of advanced solid tumors
本次新增II期病例拓展阶段主要目的为评价OH2注射液抗肿瘤疗效。
[Translation] The main purpose of this additional Phase II case expansion phase is to evaluate the anti-tumor efficacy of OH2 injection.
100 Clinical Results associated with Wuhan Binhui Biotechnology Co., Ltd. Biological Innovation Park Branch
0 Patents (Medical) associated with Wuhan Binhui Biotechnology Co., Ltd. Biological Innovation Park Branch
100 Deals associated with Wuhan Binhui Biotechnology Co., Ltd. Biological Innovation Park Branch
100 Translational Medicine associated with Wuhan Binhui Biotechnology Co., Ltd. Biological Innovation Park Branch