Trial reportBMC medicine2025
Lipid metabolism associated with efficacy of metronomic capecitabine and camrelizumab in gastrointestinal cancer: an exploratory clinical trial.
Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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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.
Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus PD-L1 Antibody Camrelizumab as Third-line Regimen to Treat HER2 Negative Advanced Gastric Cancer Patients
Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus Camrelizumab as Second-line Regimen to Treat Head and Neck Cancer or Esophageal Squamous Cancer Patients
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3)
Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
backgroundMetronomic chemotherapy shows potential to enhance efficacy of PD-1 antibodies but has not been assessed in gastrointestinal (GI) cancer. Immunotherapy efficacy can be affected by body composition and lipid metabolism of patients. We aimed to evaluate the feasibility of metronomic capecitabine plus camrelizumab as a salvage treatment of late-stage GI cancer and to explore the roles of body composition and lipid metabolism in this regimen.
methodsThis is a single-center, exploratory trial. Eligible GI cancer patients who had disease progression after standard chemotherapy were treated with metronomic capecitabine (500 mg twice daily) plus camrelizumab (200 mg on day 1 intravenously every 2 weeks). The primary endpoint was safety. Body composition indices analyzed by SliceOmatic software and lipidomics analyses using liquid chromatography-mass spectrometry were performed as exploratory investigation. Differentially expressed genes (DEGs) of C2C12 myocytes treated with metronomic dose 5-fluorouracil were detected by RNA sequencing.
resultsA total of 26 patients were enrolled. Treatment emergent adverse events (TEAEs) grade ≥ 3 occurred in five patients (19.2%). Objective response rate was 19.2% (5/26), including two patients with complete response. High skeletal muscle radiation attenuation (SMRA) was associated with disease control and better survival. Differential plasma lipids were identified in disease-controlled patients compared with those who showed disease progression. High levels of a 6-lipid signature composed of SM40:1;3, TG54:4-FA20:2, LPC(16:0), TG52:0-FA20:0, TG56:3-FA20:2, and PE(P-18:1/18:2) were associated with better survival. SMRA and this plasma lipid panel were both increased in disease-controlled patients after treatment. DEGs including prkg1, adora1, and Il15 in metronomic 5-FU treated C2C12 myocytes could be enriched into lipid metabolism pathways.
conclusionsMetronomic capecitabine plus camrelizumab is well tolerated and shows promising efficacy in GI cancer. SMRA and specific plasma lipids are associated with efficacy of this regimen and indicate the modulation effect of metronomic capecitabine on lipid metabolism. TRIAL REGISTRATIONS: NCT04508686 (Aug 11, 2020), NCT04510818 (Aug 12, 2020), NCT04932187 (Sep 17, 2021).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.