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MechanismCSF-2R stimulants |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
重组人GM-CSF溶瘤Ⅱ型单纯疱疹病毒(OH2)注射液(Vero细胞)联合mFOLFOX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 mFOLFOX in the treatment of 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mFOLFOX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 efficacy of intratumoral OH2 injection combined with mFOLFOX in the treatment of subjects with unresectable advanced or metastatic biliary tract cancer who have failed at least one line of standard therapy.
一项评价重组人GM-CSF溶瘤II型单纯疱疹病毒(OH2)注射液(Vero细胞)联合卡培他滨用于晚期结直肠癌一线维持治疗的前瞻性、多中心、开放、随机对照的II期临床研究
[Translation] A prospective, multicenter, open, randomized, controlled phase II clinical study evaluating recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection (Vero cells) combined with capecitabine for first-line maintenance treatment of advanced colorectal cancer
评价OH2注射液联合卡培他滨用于晚期结直肠癌一线维持治疗的有效性
[Translation] To evaluate the effectiveness of OH2 injection combined with capecitabine as first-line maintenance treatment for advanced colorectal cancer
评价重组人GM-CSF溶瘤II型单纯疱疹病毒(OH2)注射液对比研究者选择的挽救性化疗或最佳支持治疗(BSC)在标准治疗失败的黑色素瘤患者的III期临床研究
[Translation] A phase III study evaluating recombinant human GM-CSF oncolytic herpes simplex virus type 2 (OH2) injection versus investigator's choice of salvage chemotherapy or best supportive care (BSC) in patients with melanoma who have failed standard therapy
主要目的:
1.以研究者选择的挽救性化疗或最佳支持治疗(BSC)为对照,评价OH2注射液治疗经至少二线以上标准治疗失败的不能手术切除或转移性的黑色素瘤患者的有效性。
次要目的:
1.以研究者选择的挽救性化疗或最佳支持治疗(BSC)为对照,评价OH2注射液治疗经至少二线以上标准治疗失败的不能手术切除或转移性的黑色素瘤患者的安全性。
2.评估黑色素瘤患者对OH2注射液的免疫原性。
[Translation] Primary purpose:
1. To evaluate the effectiveness of OH2 injection in the treatment of patients with unresectable or metastatic melanoma who have failed at least two lines of standard treatment, using salvage chemotherapy or best supportive care (BSC) selected by the investigator as a control.
Secondary purpose:
1. To evaluate the safety of OH2 injection in the treatment of patients with unresectable or metastatic melanoma who have failed at least two lines of standard treatment, using salvage chemotherapy or best supportive care (BSC) selected by the investigator as a control.
2. To evaluate the immunogenicity of OH2 injection in melanoma patients.
100 Clinical Results associated with Wuhan Binhui Biotechnology Co., Ltd. Biological Innovation Park Branch
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