Trial reportJournal for immunotherapy of cancer2025
Cadonilimab combined with taxane and cisplatin as the first-line treatment of advanced esophageal squamous cell carcinoma: an open-label, multicenter phase II trial.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05522894 (A Multicenter, Phase II Clinical Study of AK104), which is not on this map. Cited by 8 papers.
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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.
A Multicenter, Phase II Clinical Study of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) Alone or in Combination With Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
Who cites it
8 citing papers in PubMed.
- Efficacy and Safety of Cadonilimab in Digestive System Neoplasms: A Systematic Review and Single-Arm Meta-Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Review
- Integrated analysis of Morusin inhibiting esophageal cancer via network pharmacology molecular dynamics simulation and in vitro validation.Discover oncology · 2026Article
- Cadonilimab (mono anti-PD-1/CTLA-4 therapy) in advanced esophageal squamous cell carcinoma.Journal for immunotherapy of cancer · 2026Article
- Immunosuppressive tumor microenvironment and immunotherapy resistance of esophageal carcinoma.Frontiers in immunology · 2026Review
- Advances and challenges in immunotherapy for advanced esophageal squamous cell carcinoma.Frontiers in immunology · 2026Review
- Bispecific antibodies in gastrointestinal cancers: current applications and future perspectives.Frontiers in oncology · 2026Review
- The Role of COQ10B in Tumor Progression and Its Association with Immune Escape in Esophageal Squamous Cell Carcinoma: A Multi-Omics and Functional Analysis.International journal of general medicine · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCadonilimab, a bispecific antibody simultaneously targeting programmed cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4, may further boost antitumor activity compared with PD-1 or programmed cell death ligand 1 (PD-L1) inhibitors. Here, we evaluated the safety and efficacy of cadonilimab combined with chemotherapy as the first-line treatment in advanced esophageal squamous cell carcinoma (ESCC).
methodsTreatment-naïve patients with unresectable locally advanced or metastatic ESCC were eligible. Cadonilimab combined with paclitaxel or nab-paclitaxel and cisplatin was administrated for up to six cycles, then cadonilimab monotherapy continued as maintenance until progressive disease or unacceptable toxicity, with a maximum of 24 months. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. Plasma cell-free DNA samples were collected before and after treatment and prepared for DNA methylation level sequencing.
resultsAs of September 27, 2024, 43 patients were enrolled with a median age of 61 years (range 44-75), 39.5% had PD-L1 combined positive score ≥10 and 95.3% had distant metastases. The ORR was 81.4% (95% CI 66.6% to 91.6%) and DCR was 97.7% (95% CI 86.2% to 99.9%). The median PFS was 7.10 months (95% CI 5.68 to 8.48) while OS remained immature. The mean pretreatment cytosine-phosphate-guanine (CpG) site methylation levels of APBA2, EPAS1, TRIM58, ITPKA and LINC00554 were significantly higher in responders than those in non-responders. Grade 3-4 treatment-related adverse events were reported in 53.5% (23/43) patients.
conclusionsCadonilimab combined with taxane and cisplatin as first-line treatment revealed encouraging antitumor activity and manageable safety in patients with advanced ESCC. DNA methylation level might be a potential biomarker for guiding patient outcomes. TRIAL REGISTRATION NUMBER: NCT05522894.
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