Trial reportTrials2016
A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Tailoring traditional Chinese medicine in cancer therapy.Molecular cancer · 2025Review
- Network pharmacology in combination with bibliometrics analysis on the mechanism of compound Kushen injection in the treatment of radiation pneumonia and lung cancer.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Single-cell RNA-sequencing uncovers compound kushen injection synergistically improves the efficacy of chemotherapy by modulating the tumor environment of breast cancer.Frontiers in immunology · 2022Article
- Rebalancing TGF-β/Smad7 signaling via Compound kushen injection in hepatic stellate cells protects against liver fibrosis and hepatocarcinogenesis.Clinical and translational medicine · 2021Article
- High Throughput Transcriptome Data Analysis and Computational Verification Reveal Immunotherapy Biomarkers of Compound Kushen Injection for Treating Triple-Negative Breast Cancer.Frontiers in oncology · 2021Article
- Compound kushen injection relieves tumor-associated macrophage-mediated immunosuppression through TNFR1 and sensitizes hepatocellular carcinoma to sorafenib.Journal for immunotherapy of cancer · 2020Article
- Anti-Tumor Activities of Bioactive Phytochemicals inCancer management and research · 2020Review
- Compound Kushen injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 37 RCTs following the PRISMA guidelines.Journal of Cancer · 2020Article
- A New Strategy for Identifying Mechanisms of Drug-drug Interaction Using Transcriptome Analysis: Compound Kushen Injection as a Proof of Principle.Scientific reports · 2019Article
- Compound Kushen Injection as an Adjunctive Therapy for the Treatment of Non-Small-Cell Lung Cancer: A Meta-Analysis of Randomized Controlled Trials.Evidence-based complementary and alternative medicine : eCAM · 2019Article
- Uncovering the Anticancer Mechanism of Compound Sophorae Decoction against Ulcerative Colitis-Related Colorectal Cancer in Mice.Evidence-based complementary and alternative medicine : eCAM · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWith the aging of the global population, an increasing number of elderly are diagnosed with advanced non-small cell lung cancer. Although systematic chemotherapy has been one of the primary treatments for advanced non-small cell lung cancer worldwide, the elderly cannot always tolerate standard platinum-based doublet chemotherapy, thus resulting in treatment failure. To reduce toxicity, single-agent chemotherapy is often used to treat the elderly with non-small cell lung cancer; however, this may increase the risk of treatment failure due to an inadequate dose. It has been shown that compound kushen injection in combination with chemotherapy can enhance the efficacy and reduce the toxicity. The aim of this trial is to assess the clinical effectiveness and safety of compound kushen injection in combination with single-agent chemotherapy versus platinum-based doublet chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer.
methodsThis multicenter study will be an open-label, randomized controlled trial. Three hundred seventy elderly patients with advanced non-small cell lung cancer will be randomly divided into experimental (n = 185) and control groups (n = 185) to receive compound kushen injection in combination with single-agent chemotherapy or standard platinum-based doublet chemotherapy for two cycles. After two cycles, the disease control rate, objective response rate, clinical symptoms, quality of life, Karnofsky Performance Status, and side effects will be assessed. Follow-up evaluations will be performed every 8 weeks to evaluate the progression-free and overall survival. DISCUSSION: Before the trial was designed, compound kushen injection was shown to be effective for lung cancer through basic experiments and clinical trials. This study will determine whether or not the efficacy of compound kushen injection in combination with single-agent chemotherapy is comparable to that of platinum-based doublet chemotherapy, and whether or not the toxicity of compound kushen injection in combination with single-agent chemotherapy is lower than that of platinum-based doublet chemotherapy.
trial registrationChiCTR-IPR-14005484 (16 November 2014).
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