A multicenter, randomized, observation-controlled clinical trial to evaluate the efficacy and safety of thymalfasin adjuvant therapy in patients with HBV-related HCC after curative resection - first announcement of the protocol.
Qiu. Shuang-Jian SJ; Zhou. Zhong-Guo ZG; Shen. Feng F; Li. Ai-Jun AJ; Chen. Min-Shan MS; Ying. Min-Gang MG; Chen. Zhong Z; Zhang. Yi-Xin YX; Sun. Hui-Chuan HC; Fan. Jia J
Key Findings
- The study is a multicenter, randomized, observation‑controlled trial in China for HBV‑related HCC after curative resection.
- Thymalfasin will be given at 1.6 mg twice weekly for 12 months as adjuvant therapy.
- Primary endpoint is 2‑year recurrence‑free survival; secondary endpoints include tumor immune microenvironment and safety.
Practical Outcomes
- At this stage there’s nothing to change in your regimen, but note the planned dose and schedule if future results prove effective. Keep an eye out for the trial outcomes, which could inform a potential adjuvant use of thymosin‑alpha‑1 for liver cancer survivors.
Summary
This paper just outlines a big new trial that will test whether giving thymosin‑alpha‑1 (called thymalfasin) after liver cancer surgery can keep the cancer from coming back. It’s a plan, not results, and it tells us the dose they’ll use (1.6 mg twice a week for a year) and that they’ll look at 2‑year recurrence‑free survival and immune changes. For now it’s mostly a heads‑up that solid data may be coming, not a ready‑to‑use protocol.
Abstract
Hepatocellular carcinoma (HCC), the third leading cause of cancer-related death worldwide, is a disease of immune microenvironment. Chronic Hepatitis B virus (HBV) infection, also an immune-related disease, is the major etiological factor for HCC especially in Asia. As an immune regulator, which has pleiotropic activities on T cells, nature killer cells and dendritic cells and so on, the efficacy of thymalfasin on HCC patients has been proven by several pilot studies as an adjuvant therapy. Combination of thymalfasin significantly improved survival and prolonged the time to tumor recurrence in patients who received transcatheter arterial chemoembolization after tumor resection. An improvement in patients' immunity has also been demonstrated. However, there is no large-scale randomized controlled study so far in resectable HCC patients. To confirm the role of thymalfasin adjuvant therapy in patients with HBV-related HCC after curative resection, a large-scale multicenter randomized controlled trial has been planned in China to investigate the effect of thymalfasin (1.6 mg twice a week for 12 months) on 2-year recurrence-free survival rate and tumor immune microenvironment. Here is the first announcement of the study protocol (ClinialTrials.gov Identifier: NCT02281266).
Study Information
pubmed
2015
2015-06-22T00:00:00.000Z
10.1517/14712598.2015.1039979
10
22