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Carcinoma, Squamous Cell clinical trials

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NCT ID: NCT04718415 Recruiting - Clinical trials for Oral Squamous Cell Carcinoma

Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

OOC-001
Start date: January 23, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to look at the efficacy and safety of sintilimab in combination with carboplatin and nab-paclitaxel in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Monoclonal antibodies, such as sintilimab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sintilimab, carboplatin, and nab-paclitaxel may work better in treating patients with oral cavity and oropharyngeal squamous cell carcinoma.

NCT ID: NCT04699994 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel

Start date: June 25, 2020
Phase: Phase 2
Study type: Interventional

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.

NCT ID: NCT04696744 Recruiting - Clinical trials for Oropharyngeal Cancer

Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)

CTCO
Start date: June 23, 2021
Phase:
Study type: Observational

Head and neck cancers (HNSCC) are primarily squamous cell cancers represented by tumors of the upper aerodigestive tract. Locally advanced stages (stages III and IV) account for 50 to 70% of all presentations. The three main risk factors are smoking, alcohol and oropharyngeal infection with human papilloma virus (HPV). Apart from HPV status, there is no biomarker for the prognosis in HSNCC patients. Circulating Tumor Cells (CTCs) can provide "real-time" information on tumor behavior and are already used in various cancers (colon, lung). Their detection has limited sensitivity and biomarkers cannot be used for early diagnosis, but may be useful during follow-up to assess local, regional or metastatic early tumor recurrence. By using blood samples at different times (at diagnosis, after initial treatment and during follow-up), we will be able to measure the variation in quantification and establish a predictive role of these CTCs for the response to treatment. Our hypothesis is that CTCs may have a key role, in addition to clinical and radiological examination, in detecting early tumor relapse. We believe that the joint consideration of clinical parameters, treatment strategy and quantification of CTCs could optimize patient follow-up and management. The CTC extraction system, ClearCell® FX from Biolidics, is an automated microfluidic enrichment system. It has the advantage of recovering fully intact and viable CTCs from a standard blood sample. The gentle sorting principle allows to preserve cell integrity and thus the expression of surface antigens. The CTCs thus isolated can then be re-cultured or analyzed by immunostaining. This high-performance technique, in operation since December 2017 in the Biochemistry Department of Pr Claire Rodriguez-Lafrasse (HCL), has demonstrated its usefulness in lung cancer. Transcriptomic analysis of CTCs can be performed at the scale of a cell after isolation of the CTCs. CTCs can then be sequenced in RNAseq either in bulk (pool of cells) or cell by cell on our Illumina (Nextseq) sequencer, in order to define the heterogeneity of the tumor. Transcriptome analysis then provides information on the state of the cell as to its position in the epithelio-mesenchymal transition thanks to a molecular signature by phenotype. A priori-free characterization is therefore possible thanks to the RNAseq single-cell. This highly sensitive and innovative technique will allow the study of the gene expression profile of CTCs.

NCT ID: NCT04688528 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC

SEMIRAHN
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

The study involves head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by primary (chemo)radiotherapy. The elective node irradiation on the contralateral side is not always mandatory and the dose may be too high. In this study, we evaluate two strategies: the impact of sentinel lymph node mapping to tailor the volumes to irradiate and the dose reduction.

NCT ID: NCT04681469 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC

PRIME
Start date: February 8, 2021
Phase: Phase 2
Study type: Interventional

We propose a window of opportunity trial to evaluate safety and efficacy of a short course of the study combination, composed by an Anti-PD-1 monoclonal antibody (Dostarlimab (TSR-042)) and a PARPi (Niraparib). The study population will be surgically resectable, HPV-negative (defined by p16 negative status) locally advanced HNSCC. Maintenance treatment will be then delivered, so to better integrate the therapeutic benefits of this drug combination. Response to neoadjuvant treatment will be evaluated by the rate of major pathologic response, morphologic, and functional imaging (MRI with functional evaluation -DWI). We anticipate that neoadjuvant and maintenance PARPi plus immunotherapy treatment could lead to a reduction of loco-regional recurrence (LRR) and distant metastasis (DM) rates in such a high-risk population. Furthermore, the window of opportunity portion of this trial will allow in vivo acquisition of valuable knowledge on mechanisms of action and primary resistance to Anti-PD-1 monoclonal antibody and PARPi in HNSCC. In this phase of the study, biological specimens will be collected (pre-treatment tumor biopsy, tissues from the surgical specimen, liquid biopsy, blood and saliva samples) as well as functional imaging (MRI).

NCT ID: NCT04675333 Recruiting - Clinical trials for Head and Neck Cancer

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Start date: May 10, 2021
Phase: Phase 2
Study type: Interventional

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

NCT ID: NCT04675294 Recruiting - Clinical trials for Head and Neck Cancer

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Start date: April 2, 2021
Phase: Phase 2
Study type: Interventional

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

NCT ID: NCT04671667 Recruiting - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

NCT ID: NCT04664582 Recruiting - Sentinel Lymph Node Clinical Trials

Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

Current guidelines in management of regional lymph node metastases for cSCC patients include surgical resection with or without adjuvant therapy as well as chemotherapy and interdisciplinary management; in advanced disease, supportive and palliative care is recommended. These guidelines also define the role of SLNB in management of high-risk cSCC as unclear and suggest further studies need to determine its utility and indications11. Currently, routine practice of performing SLNB in cSCC varies across Quebec and within Canada. At many institutions, SLNB is not routinely performed on patients with cSCC. The current standard of treatment is to observe closely when a patient is deemed to have a high-risk cancer, and if they have clinical or radiological findings of lymphadenopathy, a formal surgical neck dissection is performed. Given the comorbidities and risks involved in treatment of regional lymph nodes in cSCC, the role of SLNB in cSCC patients needs further clarification. This multicentre prospective study aims to better clarify this role and formulate suggested criteria for its indications.

NCT ID: NCT04664244 Recruiting - Radiotherapy Clinical Trials

Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Start date: December 19, 2020
Phase: Phase 2
Study type: Interventional

Patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. On the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. This study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor [EGFR] IgG1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. The primary endpoint is the objective response rate evaluated by imaging methods. The second endpoints are the progression-free survival and overall survival. The treatment toxicity is regarded as one the second endpoint.