Off-label use of sodium cantharidinate and vitamin B6 injection in cancer - a protocol for a systematic review and meta-analysis

Sep 23, 2026

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This protocol describes a systematic review and meta-analysis assessing off-label sodium cantharidinate/vitamin B6 (SC/VB6) use in oncology. In China, SC/VB6 has been authorized since 2002 for lung and primary liver cancer, yet it is widely applied to other cancer types without a comprehensive evidence synthesis. Searches span major international and Chinese databases through 31 December 2024, comparing add-on SC/VB6 plus conventional therapy versus conventional therapy alone. Primary outcomes include objective response rate and performance status, with additional efficacy and safety endpoints.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background

Methods

Outcomes and analysis

Subgroup and sensitivity analyses

Discussion

Systematic review registration

Keywords

Jin et al. Systematic Reviews (2025) 14:82 [https://doi.org/10.1186/s13643-025-02826-y](https://doi.org/10.1186/s13643-025-02826-y) Systematic Reviews PROTOCOL Open Access Off-label use of sodium cantharidinate and vitamin B6 injection in cancer: a protocol for a systematic review and meta-analysis Wenzhen Jin1, Yibin Zhang1, Shu Pang1, Dongdong Yao1 andYiwen Huang1* Abstract Background In China, sodium cantharidinate/vitamin B6 (SC/VB6) injection has been approved since 2002 for the treatment of lung cancer and primary liver cancer. In addition to these authorized indications, clinical application of SC/VB6 is also common in various other types of cancer. However, there is a lack of comprehensive understanding on this topic. Thus, this systematic review and meta-analysis aims to consolidate evidence regarding the efficacy and safety of off-label use of SC/VB6 in oncology. Methods International databases including PubMed, Embase, Cochrane Library, Web of Science, and CINAHL Plus, as well as Chinese databases including China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Wanfang, will be searched from the inception to 31 December 2024. Comparative studies that evaluated the add-on effect of SC/VB6 to conventional cancer treatments against the use of conventional treatments alone will be considered in the scope of this review. The primary outcomes are objective response rate and performance status. Secondary outcomes are disease control rate (DCR), progression-free survival (PFS), diseasefree survival (DFS), overall survival (OS), and adverse events (AEs) . Depending on heterogeneity, data will be synthesized using either the Mantel–Haenszel fixed-effect or the DerSimonian and Laird random-effect model. Subgroup analyses will be conducted for the following variables: type of cancer, study design, SC/VB6 dosage, treatment duration, and combined therapies, provided that each subgroup contains at least two studies. Sensitivity analyses will be performed on efficacy outcomes. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) will be utilized to appraise the overall quality of evidence. Discussion This review will encompass both randomized controlled trials (RCTs) and cohort studies, thereby enabling us to synthesize and assess evidence across experimental and real-world observational settings. Our findings will contribute to a better understanding on the benefit-risk profile regarding the off-label use of SC/VB6 in oncology, guiding the trajectory of future research, and offering a robust scientific foundation to inform clinical and regulatory decision-making process. Systematic review registration PROSPERO CRD42024504977 . Keywords Off-label use, Sodium cantharidinate/vitamin B6, Cancer, Systematic review, Meta-analysis *Correspondence: Yiwen Huang [yiwen.huang2@clinflash.com](yiwen.huang2@clinflash.com) 1 Scientific Affairs Department, Clinflash Healthcare Technology (Jiaxing) Co., Ltd, Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai 200051, People’s Republic of China Background Cancer represents a heterogeneous group of diseases resulting from abnormal proliferation of cells that damage adjacent cells or organs and can spread to other parts of the body [1, 2]. Globally, cancer is a leading cause of premature death with rapid growth of incidence and © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third

FAQs

What is the main purpose of this review protocol?

To consolidate evidence on the efficacy and safety of off-label SC/VB6 use in oncology by conducting a systematic review and meta-analysis.

Which databases and time period will be searched?

PubMed, Embase, Cochrane Library, Web of Science, and CINAHL Plus, plus CNKI, CBM, and Wanfang, from inception to 31 December 2024.

What are the primary outcomes and key secondary outcomes?

Primary outcomes are objective response rate and performance status. Secondary outcomes include DCR, PFS, DFS, OS, and adverse events.

Sep 23, 2026

Uploaded by Ophelia