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Carcinoma, Squamous Cell clinical trials

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NCT ID: NCT06272214 Recruiting - Clinical trials for Adjuvant Radiotherapy

Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0. Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients.

NCT ID: NCT06269341 Recruiting - Clinical trials for Outcomes of Smoker and Drinker After Esophagectomy

Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy

OSinEC
Start date: February 1, 2010
Phase:
Study type: Observational

Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank

NCT ID: NCT06265285 Recruiting - Clinical trials for Hepatocellular Carcinoma

Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.

NCT ID: NCT06259838 Completed - Clinical trials for Oral Cavity Squamous Cell Carcinoma; Readmission

Oral Cavity Squamous Cell Carcinoma and Readmission: Rates, Causes, and Risk Factors.

Start date: January 1, 2023
Phase:
Study type: Observational

We sought to comprehend the rates and causes of unplanned hospital readmission within 60 days following oral cancer surgery

NCT ID: NCT06258811 Recruiting - Clinical trials for Oral Squamous Cell Carcinoma

Neoadjuvant Immunochemotherapy for LAOSCC

Start date: February 20, 2024
Phase: Phase 3
Study type: Interventional

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.

NCT ID: NCT06256588 Recruiting - Clinical trials for Neoplasms, Head and Neck

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

JADE
Start date: March 21, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)

NCT ID: NCT06256185 Completed - Clinical trials for Lymph Node Metastasis

Machine Learning to Predict Lymph Node Metastasis in T1 Esophageal Squamous Cell Carcinoma

Start date: January 15, 2010
Phase: N/A
Study type: Interventional

Existing models do poorly when it comes to quantifying the risk of Lymph node metastases (LNM). This study generated elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these for LNM in patients with T1 esophageal squamous cell carcinoma.

NCT ID: NCT06252974 Not yet recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Accurate Diagnosis of the Invasion Depth in ESCC by a Deep Neural Network Analysis of NBI Endoscopy Data

Start date: April 25, 2024
Phase:
Study type: Observational

The goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. The main question it aims to answer is: • To get early accurate diagnosis of the invasion depth of esophageal squamous cell carcinoma by narrow-band imaging endoscopy data. Participants' clinical informations from routine examinations and treatments will be collected, there will be no harm to participants.

NCT ID: NCT06251050 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy

Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.

NCT ID: NCT06248996 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

ARTSCAN VI
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy. In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.