Trial reportBMC medicine2014
Selective intra-arterial infusion of rAd-p53 with chemotherapy for advanced oral cancer: a randomized clinical trial.
Trial report in BMC medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Interventions for the treatment of oral cavity and oropharyngeal cancer: chemotherapy.The Cochrane database of systematic reviews · 2021Pooled it
- Recombinant Human Adenovirus-Medicina (Kaunas, Lithuania) · 2021Pooled it
- Functional and aesthetic results of the Z-shaped and straight lower lip-splitting incision: a randomized clinical trial.Scientific reports · 2024Trial
- Clinical Progress in Virotherapy: Application and Future Prospects in Head and Neck Cancer.International journal of molecular sciences · 2026Review
- Discovery of Drugs Targeting Mutant p53 and Progress in Nano-Enabled Therapeutic Strategy for p53-Mutated Cancers.Biomolecules · 2025Review
- Expanding the role of interventional oncology for advancing precision immunotherapy of solid tumors.Molecular therapy oncolytics · 2022Review
- Expert consensus on the clinical application of recombinant adenovirus human p53 for head and neck cancers.International journal of oral science · 2021Article
- Review
- The Balance between Differentiation and Terminal Differentiation Maintains Oral Epithelial Homeostasis.Cancers · 2021Review
- Review
- Therapeutic Options in Unresectable Oral Squamous Cell Carcinoma: A Systematic Review.Cancer management and research · 2021Review
- Combined effect of recombinant human adenovirus p53 and curcumin in the treatment of liver cancer.Experimental and therapeutic medicine · 2020Article
- Therapeutic effects of lenvatinib in combination with rAd-p53 for the treatment of non-small cell lung cancer.Oncology letters · 2018Article
- Improving adenoviral vectors and strategies for prostate cancer gene therapy.Clinics (Sao Paulo, Brazil) · 2018Review
- Article
- p53 molecular approach to diagnosis and treatment of esophageal squamous cell carcinoma.Annals of gastroenterological surgery · 2018Review
- Recombinant adenovirus p53 combined with radiotherapy improves efficacy and safety in the treatment of head and neck lymphoma.Cancer biomarkers : section A of Disease markers · 2018Article
- Review
- Antitumor effects of recombinant human adenovirus-p53 against human cutaneous squamous cell carcinoma in mice.Experimental and therapeutic medicine · 2016Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn this study, a combination of recombinant adenoviral p53 (rAd-p53) gene therapy and intra-arterial delivery of chemotherapeutic agents for treatment of oral squamous cell carcinoma was evaluated.
methodsIn total, 99 patients with stage III or IV oral carcinoma who had refused or were ineligible for surgery were enrolled in a randomized, placebo-controlled, double-blind, phase III clinical trial. They were randomly assigned to group I (n = 35; intra-arterial infusion of rAd-p53 plus chemotherapy), group II (n = 33; intra-arterial infusion of rAd-p53 plus placebo chemotherapy), or group III (n = 31; intra-arterial infusion of placebo rAd-p53 plus chemotherapy).
resultsThe median length of follow-up was 36 months (range, 3 to 86 months). During follow-up, 16 patients in group I, 20 in group II, and 22 in group III died. Group I (48.5%) had a higher complete response rate than groups II (16.7%) and III (17.2%) (P = 0.006). The rate of non-responders in group I was significantly lower than that in groups II and III (P < 0.020). A log-rank test for survival rate indicated that group I had a significantly higher survival rate than group III (P = 0.019). The survival rate of patients with stage III but not stage IV oral cancer was significantly higher in group I than in group III (P = 0.015, P = 0.200, respectively). The survival rate of patients with stage IV did not differ significantly among the three groups. Or the 99 patients, 63 patients experienced adverse events of either transient flu-like symptoms or bone marrow suppression, while 13 patients had both these conditions together. No replication-deficient virus was detected in patient serum, urine, or sputum. rAd-p53 treatment increased Bax expression in the primary tumor of 80% of patients, as shown by immunohistochemical staining.
conclusionsIntra-arterial infusion of combined rAd-p53 and chemotherapy significantly increased the survival rate of patients with stage III but not stage IV oral cancer, compared with intra-arterial chemotherapy. Intra-arterial infusion of combined rAd-p53 and chemotherapy may represent a promising alternative treatment for oral squamous cell carcinoma.
trial registrationChiCTR-TRC-09000392 (Date of registration: 2009-05-18).
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What OpenQuestion holds
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.