In China, CNSI-Fe halted tumor growth in 16 of 19 patients — South China Morning Post

China has completed the first phase of a clinical trial of the intratumoral CNSI-Fe injection for patients with advanced solid tumors that progressed despite systemic treatment. The study involved 19 people: tumor growth stopped in 16 of them, or 84.2%, while tumor shrinkage was recorded in two patients.

As South China Morning Post reports, the drug combines a clinically approved nanocrystalline carbon injection with ferrous sulfate. It was administered directly into tumors at different doses, while doctors assessed the response of target and distant lesions.

Results of the first phase

The overall objective response rate, meaning tumor shrinkage, was 10.5%. The disease control rate, in which tumors did not continue to grow, reached 84.2%. The effect in tumors into which the drug was injected was better than across all systemic lesions.

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Participants had sarcoma, head and neck tumors, pancreatic cancer, non-small cell lung cancer, ovarian cancer, breast cancer, and vulvar cancer. Sixteen of them had stage IV metastatic tumors. All patients had previously received at least two lines of systemic therapy, including chemotherapy, radiation therapy, and immunotherapy.

Safety and the next stage

The most common adverse reactions were pain at the injection site, which occurred in 89.5% of participants, and elevated blood pressure, in 52.6%. One patient discontinued participation because of a hypersensitivity reaction. The study reported no severe hematological or hepatorenal toxicity.

The first phase was conducted at three hospitals in the provinces of Sichuan, Hubei, and Shandong under the leadership of Professor Wang Yongsheng of the Oncology Center at West China Hospital. The second phase of the trial is already underway at ten Chinese hospitals, where the safety and efficacy of CNSI-Fe will be assessed in 52 patients. The study authors noted that the single-arm trial has limitations and requires further verification in randomized phase II–III studies.