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The purpose of this study was to determine the bioequivalence of two formulations of Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer, under fasting condition. These data were to be evaluated statistically to determine if the products meet bioequivalence
PRIMARY OBJECTIVES:
I. To estimate major pathological response rate. (Resectable and borderline resectable groups [treatment naive or previously treated]) II. To estimate 6-month disease control rate. (Locally advanced groups [treatment naive or previously treated])
SECONDARY OBJECTIVES:
I. To
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or a combination of investigational drugs to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug
Multicenter, international, comparative, randomized, open-label, phase II study conducted in two parallel groups.
The study population will consist of male and female patients aged ≥ 18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based
This is a Phase IIB open label immunotherapy protocol called "StimVax". The protocol design is based upon information obtained from a previous Phase IIA dose level and dose frequency ranging study. The population targeted is MSI-S metastatic colorectal cancer previously treated with two lines of
This parallel, randomized, open-label study 326 patients with metastatic ( adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive 9 cycles FOLFOX6 or mFOLFIRINOX.
Stratification factors include ECOG,
The experimental group and the control group were administered until the disease progression assessed by the RECIST V1.1 standard (unless The investigator evaluates that the subject continues to have clinical benefits, and the subject can be allowed to continue receiving treatment), start new
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has
Background - Rationale Aflibercept The addition of aflibercept to the standard FOLFIRI regimen as second-line therapy was evaluated in a large phase III study (EFC10262-VELOUR). This combination significantly improved both PFS (4.7 to 6.9 months, HR=0.76; P=<0.001) and OS (12.1 to 13.5 months,
PRIMARY OBJECTIVE:
I. To determine the feasibility of administering dinutuximab in combination with irinotecan and temozolomide in the frontline Post-Consolidation setting in patients with high-risk neuroblastoma who have undergone Induction and Consolidation therapy.
SECONDARY OBJECTIVES:
I. To