评价呋喹替尼联合信迪利单抗对比研究者选择的化疗作为晚期子宫内膜癌二线治疗的疗效和安全性的随机对照、开放、多中心III期临床研究
[Translation] A randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of fruquintinib combined with sintilimab versus chemotherapy selected by investigators as second-line treatment for advanced endometrial cancer
主要目的:评价呋喹替尼联合信迪利单抗对比TPC治疗晚期子宫内膜癌的疗效。
次要目的:评价呋喹替尼联合信迪利单抗对比TPC治疗晚期子宫内膜癌的其他疗效;评价呋喹尼联合信迪利单抗对比TPC治疗晚期子宫内膜癌的安全性和耐受性;评价呋喹替尼联合信迪利单抗在晚期子宫内膜癌患者的药代动力学(PK)特征;评价呋喹替尼联合信迪利单抗对比TPC治疗晚期子宫内膜癌对患者生活质量评分的影响。
探索性目的:评价生物标志物对疗效的影响。
[Translation] Primary objective: To evaluate the efficacy of fruquintinib combined with sintilimab versus TPC in the treatment of advanced endometrial cancer.
Secondary objective: To evaluate other efficacy of fruquintinib combined with sintilimab versus TPC in the treatment of advanced endometrial cancer; To evaluate the safety and tolerability of fruquintinib combined with sintilimab versus TPC in the treatment of advanced endometrial cancer; To evaluate the pharmacokinetic (PK) characteristics of fruquintinib combined with sintilimab in patients with advanced endometrial cancer; To evaluate the effect of fruquintinib combined with sintilimab versus TPC in the treatment of advanced endometrial cancer on the quality of life score of patients.
Exploratory objective: To evaluate the effect of biomarkers on efficacy.
评价索凡替尼联合卡瑞利珠单抗、白蛋白结合型紫杉醇、吉西他滨对比白蛋白结合型紫杉醇联合吉西他滨一线治疗转移性胰腺癌的疗效和安全性的多中心、随机、开放、阳性对照的 II/III 期临床研究
[Translation] A multicenter, randomized, open-label, positive-controlled phase II/III clinical study to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel combined with gemcitabine as the first-line treatment for metastatic pancreatic cancer
主要目的:
评估索凡替尼联合卡瑞利珠单抗、白蛋白结合型紫杉醇+吉西他滨(AG)一线治疗转移性胰腺癌的安全性和耐受性
评价索凡替尼联合卡瑞利珠单抗、AG对比AG一线治疗转移性胰腺癌的疗效
[Translation] Main purpose:
To evaluate the safety and tolerability of surufatinib combined with carrelizumab, albumin-bound paclitaxel + gemcitabine (AG) as first-line treatment for metastatic pancreatic cancer
To evaluate the efficacy of surufatinib combined with carrelizumab, AG and AG as first-line treatment for metastatic pancreatic cancer
/ Active, not recruitingPhase 1/2 评价呋喹替尼单药或联合信迪利单抗治疗晚期实体瘤患者的安全性、耐受性、药代动力学特征和初步疗效的Ib/II期临床研究
[Translation] A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of fruquintinib alone or in combination with sintilimab in patients with advanced solid tumors
评价剂量递增阶段呋喹替尼联合信迪利单抗治疗晚期实体瘤患者的安全性、耐受性,观察可能出现的剂量限制性毒性、最大耐受剂量和/或确定联合治疗的II期推荐剂量和给药方式。基于研究者的肿瘤评估数据评价研究扩展阶段呋喹替尼联合信迪利单抗在晚期实体瘤患者各队列中的初步疗效(除子宫内膜癌队列)(RECIST 1.1)。基于独立影像评估委员会(IRC)的肿瘤评估数据评价呋喹替尼联合信迪利单抗治疗既往接受系统治疗后疾病进展且不适合进行根治性手术治疗或放疗的晚期错配修复完整(pMMR)(中心实验室检测确认)子宫内膜癌患者的肿瘤客观缓解率(ORR)(RECIST 1.1)(子宫内膜癌队列)。 基于研究者的肿瘤评估数据评价呋喹替尼单药治疗组在子宫内膜癌患者中的初步疗效。
[Translation] To evaluate the safety and tolerability of fruquintinib combined with sintilimab in the dose escalation phase in patients with advanced solid tumors, observe possible dose-limiting toxicities, maximum tolerated doses, and/or determine the recommended Phase II dose and administration method for combination therapy. To evaluate the preliminary efficacy of fruquintinib combined with sintilimab in each cohort of patients with advanced solid tumors in the expansion phase of the study (except the endometrial cancer cohort) based on the tumor assessment data of the investigator (RECIST 1.1). To evaluate the tumor objective response rate (ORR) (RECIST 1.1) of fruquintinib combined with sintilimab in patients with advanced mismatch repair complete (pMMR) (confirmed by central laboratory testing) endometrial cancer who have disease progression after previous systemic treatment and are not suitable for radical surgery or radiotherapy (endometrial cancer cohort) based on the tumor assessment data of the independent imaging review committee (IRC). To evaluate the preliminary efficacy of the fruquintinib monotherapy group in patients with endometrial cancer based on the tumor assessment data of the investigator.
100 Clinical Results associated with Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
0 Patents (Medical) associated with Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
100 Deals associated with Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
100 Translational Medicine associated with Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.