View clinical trials related to HNSCC.
Filter by:Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions. Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features. Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis.
This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.
This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.
An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.
Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: 1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins; 2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood; 3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF. It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.