Effectiveness and safety of human type 5 recombinant adenovirus (H101) in malignant tumor with malignant pleural effusion and ascites: A multicenter, observational, real-world study.

BACKGROUND: The aim of this study was to analyze the effectiveness and safety of H101 in Chinese patients with malignant pleural effusion and ascites (MPE/MA) in the real world. METHODS: This multicenter, observational, real-world study recruited patients with MPE/MA caused by malignant tumor receiving H101-containing treatment between January 2020 and June 2022. Effectiveness was evaluated by overall remission rate (ORR), and safety was evaluated based on adverse events (AEs). Subgroup analysis was performed on patients grouped according to tumor type, the volume of MPE and MA, and dosage of H101. RESULTS: A total of 643 eligible patients were enrolled, and 467 received H101 monotherapy and 176 received H101 combined with chemotherapy. The ORR of total patients was60.3% with 388 case of PR. In the H101 monotherapy group, the decrease of MPE or MA was achieved in 282 (60.4%, PR) patients, 176 (37.7%, NC) patients showed no change in volume of MPE or MA, and nine (1.9%, PD) patients showed an increase, yielding an ORR of 60.4% (282/467). The ORR for the combination therapy group was 60.2% (106/176), with 106 cases of PR, 69 cases of NC and one case of PD. Subgroup analyses based on tumor type, volume of MPE and MA, and dosage of H101 all showed high ORR, approximately 60%. The main AEs associated with H101-containing regimens were fever, nausea and vomiting. No serious AEs occurred in both groups. CONCLUSION: Encouraging clinical benefits and manageable toxicity of H101 against MPE/MA were preliminarily observed in the real-world clinical setting, indicating that the H101-containing regimen is reliable, safe, and feasible, providing a novel and effective option for the treatment of this disease.

Advances in the clinical development of oncolytic viruses.

OBJECTIVES: Oncolytic viruses (OVs) are natural or recombinant viruses that selectively infect and kill cancer cells without harming normal cells. This review aimed to explore some ongoing and completed clinical studies on OVs, in China and worldwide, to depict a comprehensive landscape of OV clinical trials, and summarize the existing evidence on safety and effectiveness of oncolytic therapy against tumors. METHODS: Used the Center for Drug Evaluation of China National Medical Products Administration (NMPA), Chinese Clinical Trial Registry (ChiCTR), International Clinical Trials Registry Platform, ClinicalTrials.gov website, China National Knowledge Infrastructure (CNKI), and PubMed. RESULTS: As of October 1, 2021, 408 clinical trials on 31 OV products have been conducted, with oncolytic DNA viruses being the most investigated ones; phase I and phase II clinical studies accounted for approximately 80% of all studies. Published clinical studies have shown that OVs, such as H101, T-VEC, G47Δ, OH2, T3011, and Pelareorep, have significant anti-tumor effects on various tumors, with only mild adverse events. When OVs are used together with antiviral drugs in the clinic, drug interactions should be considered based on the sensitivity of OVs to antiviral drugs. CONCLUSIONS: OVs exhibit accurate oncolysis and favorable safety, and have positive effects on a variety of tumor treatments. It is worth noting that most of the OVs under development are still in their early stages, which is both a challenge and a promising prospect.

Cellulose nanocrystals/fluorinated polyacrylate soap-free emulsion prepared via RAFT-assisted Pickering emulsion polymerization.

Cellulose nanocrystals/fluorinated polyacrylate soap-free emulsion was successfully synthesized via RAFT-assisted Pickering emulsion process using modified cellulose nanocrystals as particle stabilizers. The cellulose nanocrystals were organically modified by linear triblock copolymer poly(2-(dimethylamino) ethyl methacrylate)-b-poly(glycidyl methacrylate)-b-poly(2,2,3,4,4,4-Hexafluorobutyl acrylate) (PDMAEMA-b-PGMA-b-PHFBA) with reactive trithiocarbonate group. Transmission electron microscopy (TEM) and scanning electron microscopy (SEM) analyses showed that modified cellulose nanocrystals were armored on the surface of spherical particles. The morphology and particle size of the resulting products depended on the pH value of particle dispersion. When the value of pH increased from 1.06 to 2.97, the spherical-like particles size decreased from 763 nm to 253 nm. However, with pH value increasing to 6.85, the particle size increased to 394 nm. Furthermore, a possible mechanism for the formation of the cellulose nanocrystals/fluorinated polyacrylate nanoparticles with core-shell structure was proposed.