Clinical Research Directory

Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma

The goal of this clinical trial is to evaluate the anti-tumor activity, safety and tolerability of the combination of Sacituzumab govitecan and Tagitanlimab as neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma (HNSCC). It will also explore potential biomarkers related to the efficacy of this combined therapy. The main questions it aims to answer are: Does the combination of Sacituzumab govitecan and Tagitanlimab improve the major pathological response rate (MPR) in patients with resectable HNSCC? What adverse reactions (side effects) do participants experience when receiving this combined neoadjuvant therapy? Does this combined therapy improve participants' objective response rate (ORR), survival time and quality of life? This is a single-arm, open-label, prospective Phase II clinical study conducted at West China Hospital of Sichuan University. A total of 30 eligible patients will be enrolled, and no placebo control will be used. The study will evaluate the efficacy and safety of the combined therapy by monitoring clinical indicators, pathological results and adverse events throughout the trial. Participants will: Receive Sacituzumab govitecan (5mg/kg) and Tagitanlimab (900mg) intravenously every 2 weeks, for a total of 2 treatment cycles. Undergo surgical resection 3-6 weeks after completing the neoadjuvant therapy, followed by adjuvant therapy (concurrent chemoradiotherapy or radiotherapy) based on pathological risk factors. Visit the clinic regularly for physical examinations, laboratory tests (such as blood routine, liver and kidney function), imaging examinations (such as head and neck MRI/CT) and safety checkups according to the study schedule. Provide biological samples (peripheral blood, tumor tissue, saliva, feces) at specified time points for biomarker detection. Complete quality-of-life questionnaires (such as EORTC QLQ-C30) regularly to assess changes in daily functioning. Note: Participants will not be charged for the study drugs (Sacituzumab govitecan and Tagitanlimab ), and will receive appropriate subsidies for study-related visits and blood collection. The research team will provide active treatment and corresponding compensation if participants experience study-related adverse reactions.

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). 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. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.

Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer

This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower progression and longer survival. Decitabine is also a clinically active demethylating agent, and may help make tumor cells more sensitive to radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. External beam radiation therapy (EBRT) is a type of radiation that uses a machine to aim high-energy rays at the tumor from outside the body. Chemotherapy drugs 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 decitabine in combination with standard of care surgery, radiation and/or chemotherapy may be safe, tolerable, and/or effective in treating patients with surgically resectable HPV-negative head and neck squamous cell cancers.

Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer

This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery. The names of the study drugs involved in this research study are: * pembrolizumab (a type of immunotherapy) * docetaxel (a type of chemotherapy) * cisplatin (a type of chemotherapy) * carboplatin (a type of chemotherapy)