Clinical trials

A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer. Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX). Participants will: * Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. * Receive FOLFOX * Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX. * Be recommended to undergo efficacy assessments every 8 weeks (±7 days). * Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses. * Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years. The Blinded Independent Central Review (BIRC) will assess: * Objective Response Rate (ORR) within 16 weeks. * Disease Control Rate (DCR) within 16 weeks. * Duration of Response (DoR). * Progression-Free Survival (PFS). The investigators will assess: * ORR within 16 weeks. * DCR within 16 weeks. * DoR. * PFS. * Overall Survival (OS). * Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations. * Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.

Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.