Trial reportThe oncologist2022
A Phase II Study of Pembrolizumab in Combination with Capecitabine and Oxaliplatin with Molecular Profiling in Patients with Advanced Biliary Tract Carcinoma.
Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03111732 (A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin), which is not on this map. Cited by 31 papers.
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.
A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in Subjects With Advanced Biliary Tract Carcinoma (BTC)
Who cites it
31 citing papers in PubMed, 43 citations in OpenAlex.
- Comprehensive molecular characterization to predict immunotherapy response in advanced biliary tract cancer: a phase II trial of pembrolizumab.Oncology research · 2025Trial
- Efficacy and safety of camrelizumab, apatinib, and capecitabine combination therapy in advanced biliary tract cancer: a phase 2, nonrandomized, prospective study.The oncologist · 2024Trial
- Review
- New progress and clinical research translation of immune checkpoint inhibitors in systemic therapy of gallbladder cancer.Frontiers in immunology · 2026Review
- Research progress on immune checkpoint inhibitors in intrahepatic cholangiocarcinoma.Annals of medicine · 2025Review
- Targeting pattern recognition receptors for cancer therapy: Mechanisms and strategies.Acta pharmaceutica Sinica. B · 2025Review
- Chemoimmunotherapy in Advanced Biliary Tract Cancers: A Meta-Analysis of Clinical Outcomes.Biomedicines · 2025Review
- Targeted therapies and immunotherapies for unresectable cholangiocarcinoma.Chinese medical journal · 2025Review
- Comparative genomic analysis of key oncogenic pathways in hepatocellular carcinoma among diverse populations.medRxiv : the preprint server for health sciences · 2025Article
- Comparing Immunotherapy Versus Chemotherapy Alone as Second-Line Therapy for Malignant Tumors of the Biliary Tract: A Retrospective Study.Clinical Medicine Insights. Oncology · 2025Article
- Nomograms predicting benefit after immunotherapy in oral bifidobacteria supplementation ICC patients: a retrospective study.BMC cancer · 2024Article
- Overcoming Resistance to Immune Checkpoint Blockade in Liver Cancer with Combination Therapy: Stronger Together?Seminars in liver disease · 2024Review
- Current and Future Therapeutic Targets for Directed Molecular Therapies in Cholangiocarcinoma.Cancers · 2024Review
- Recent Advances in Systemic Therapy for Advanced Intrahepatic Cholangiocarcinoma.Liver cancer · 2024Review
- Lineage and ecology define liver tumor evolution in response to treatment.Cell reports. Medicine · 2024Article
- Combined immune checkpoint inhibition with durvalumab and tremelimumab with and without radiofrequency ablation in patients with advanced biliary tract carcinoma.Cancer medicine · 2024Article
- Infiltrating T lymphocytes and tumor microenvironment within cholangiocarcinoma: immune heterogeneity, intercellular communication, immune checkpoints.Frontiers in immunology · 2024Review
- Adjuvant chemotherapy combined with immunotherapy in patients with cholangiocarcinoma after radical resection.Cancer medicine · 2023Article
- Tumor immune microenvironment and the current immunotherapy of cholangiocarcinoma (Review).International journal of oncology · 2023Review
- Preclinical and clinical studies of immunotherapy for the treatment of cholangiocarcinoma.JHEP reports : innovation in hepatology · 2023Review
Corrections and comments
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Authors and funding
16 authors at 1 institution in 1 country.
Funding
Abstract
backgroundWe conducted a phase II study of the combination of pembrolizumab with capecitabine and oxaliplatin (CAPOX) in patients with advanced biliary tract carcinoma (BTC) to assess response rate and clinical efficacy. Exploratory objectives included correlative studies of immune marker expression, tumor evolution, and immune infiltration in response to treatment. PATIENTS AND
methodsAdult patients with histologically confirmed BTC were enrolled and received oxaliplatin and pembrolizumab on day 1 of cycles 1-6. Capecitabine was administered orally twice daily as intermittent treatment, with the first dose on day 1 and the last dose on day 14 of cycles 1-6. Starting on cycle 7, pembrolizumab monotherapy was continued until disease progression. The primary endpoint was progression-free survival (PFS). Secondary endpoints were safety, tolerability, feasibility, and response rate. Immunohistochemistry (IHC) for PD-L1 and immune infiltrates was analyzed in paired tumor biopsies, as well as bulk transcriptome and exome profiling for five patients and single-cell RNA sequencing for one partial responder.
resultsEleven patients enrolled, three of whom had received no prior systemic therapy. Treatment was well tolerated, and the most common treatment-related grade 3 or 4 adverse events were lymphocytopenia, anemia, and decreased platelet count. Three patients (27.3%) achieved a partial response, and six (54%) had stable disease. The disease control rate was 81.8%. The median PFS was 4.1 months with a 6-month PFS rate of 45.5%. Molecular profiling suggests qualitative differences in immune infiltration and clonal evolution based on response.
conclusionCapecitabine and oxaliplatin in combination with pembrolizumab is tolerable and a potentially effective treatment for refractory advanced BTC. This study highlights a design framework for the precise characterization of individual BTC tumors.
trial registrationThis study was registered in ClinicalTrials.gov (NCT03111732).
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Registered trials
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.