Trial reportBMC medicine2025
Hepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with sorafenib for advanced hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (Double-IA-001): a phase II 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 trial NCT07636798 (Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy), which is not on this map. Cited by 11 papers, 2 of them syntheses 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.
Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib/II, Single-arm Clinical Study
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative efficacy of combination regimens based on interventional therapy and immune checkpoint inhibitors (ICIs) in patients with intermediate- and advanced-stage hepatocellular carcinoma: a systematic review, meta-analysis, and network meta-analysis.Cancer immunology, immunotherapy : CII · 2026Pooled it
- Pooled it
- Efficacy and safety of DEB-TACE combined with transarterial TQB2450 infusion and oral Anlotinib as first-line treatment in advanced hepatocellular carcinoma: a single-arm phase II study.Frontiers in immunology · 2025Trial
- Hepatic arterial infusion or intravenous infusion of adebrelimab, combined with bevacizumab and HAIC of the FOLFOX regimen for advanced unresectable hepatocellular carcinoma (HAIBrave-001 trial): a study protocol of a prospective, double-arm, phase II trial.Journal of gastrointestinal oncology · 2026Article
- Safety and Efficacy of Adebrelimab plus Apatinib Combined with Hepatic Artery Infusion Chemotherapy for the Treatment of Unresectable Hepatocellular Carcinoma: A Retrospective Study.ACS pharmacology & translational science · 2026Article
- A simplified MRI‑based risk score and nomogram to predict initial objective response in unresectable hepatocellular carcinoma treated with HAIC, targeted therapy, and immunotherapy: a multicenter study.Abdominal radiology (New York) · 2026Article
- Immunotherapy in hepatocellular carcinoma: translating mechanistic insights into clinical advances.Clinical and experimental medicine · 2026Review
- Neoadjuvant Hepatic Arterial Infusion Chemotherapy with FOLFOX Plus Tislelizumab for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: Efficacy, Safety and Biomarker Exploration.Journal of hepatocellular carcinoma · 2026Article
- Article
- A Retrospective Study of Hepatic Arterial Infusion Chemotherapy Combined with Tyrosine Kinase Inhibitors and PD-1 Inhibitors in Hepatocellular Carcinoma Patients with Main Portal Vein Tumor Thrombus (VP4).Journal of hepatocellular carcinoma · 2026Article
- Predictors of recurrence after conversion therapy in unresectable hepatocellular carcinoma treated with HAIC, bevacizumab, and sintilimab.Frontiers in immunology · 2025Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundHepatic arterial infusion chemotherapy (HAIC) with a combination of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) has shown excellent local control for patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC). In China, both camrelizumab (a programmed cell death-1 [PD-1] inhibitor) and sorafenib have been approved for the first-line treatment of advanced HCC. This study aimed to investigate the efficacy and safety of hepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with sorafenib in BCLC stage C advanced HCC.
methodsThis was a single-arm phase II trial (ChiCTR2100041874) with a Simon's two-stage design. Eligible patients were given a maximum of 6 cycles of hepatic artery infusion with FOLFOX chemotherapy plus camrelizumab (200 mg once every 3 weeks). Sorafenib (400 mg orally twice daily) was given since day 3 after the completion of the first cycle of hepatic artery infusion until disease progression, intolerable toxicity, or conversion to surgical resection. The primary endpoint was objective response rate (ORR) based on the modified Response Evaluation Criteria In Solid Tumors (mRECIST).
resultsBetween January 4, 2021, and December 11, 2023, 25 patients were enrolled. Eleven patients had partial response, with an ORR of 44.0% (95% CI, 24.6-63.5%). The primary endpoint was not met, and the study failed to enter the second stage. Median progression-free survival was 4.87 months (95% CI, 2.07-7.66), with a 12-month rate of 23.2%. Median overall survival was 8.87 months (95% CI, 8.17-9.57), with 12- and 24-month rates of 40.3% and 26.9%, respectively. Two (8.0%) patients received curative resection after the study treatment. Grade ≥ 3 treatment-related adverse events occurred in 19 (76.0%) patients, with the most common being decreased lymphocyte count (13 [52.0%]), increased aspartate aminotransferase (11 [44.0%]), and increased alanine aminotransferase (seven [28.0%]).
conclusionsHepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with oral sorafenib shows manageable safety profile but modest antitumor activity in patients with BCLC stage C advanced HCC.
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