Active clinical trials for "Squamous Cell Carcinoma of Head and Neck"

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)

Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.

To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy. Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints.

Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.

In this study, 100 patients with resectable head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma) were enrolled, who were combined with tirelizumab, carboplatin and albumin-binding paclitaxel before and after surgery. Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment. At the same time, clinical information of patients, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc. were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study. Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response (MPR) rates in the experimental group. The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during the course of this study and during follow-up, the incidence of adverse events in the experimental and control groups will be compared, and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated. Secondary Purpose One-year event survival rate and event-free survival (EFS) of enrolled patients were evaluated (five years); Pathological complete response rate (pCR) of enrolled patients was evaluated (5 years); pTR of enrolled patients was evaluated; Overall survival (OS) of enrolled patients was evaluated (5 years); Radiological response of enrolled patients was assessed; The rate of operation delay of enrolled patients was evaluated;

In patients with locally advanced head and neck squamous cell carcinoma undergoing standard surgical treatment after neoadjuvant immunochemotherapy, can PD-1 inhibitor therapy be used instead of adjuvant radiotherapy for both primary and lymph node pathology? To provide further evidence-based medical evidence for the late precision treatment of HNSCC patients after neoadjuvant immunochemotherapy. Avoid the side effects caused by excessive radiotherapy, especially avoid the occurrence of second primary cancer, radiation osteonecrosis and other diseases. Main study endpoint: A randomized controlled, non-inferiority, multicentre Phase III trial was conducted to investigate the difference in 5-year overall survival (OS) between experimental group (Group B) and control group (group A) in patients undergoing standard surgical treatment after neoadjuvant immunochemotherapy for locally advanced HNSCC, with both primary and lymph node pathology revealed by pCR. At the same time, adverse events and safety were evaluated according to NCI-CTCAE 5.0 criteria and RTOG later radiotherapy damage evaluation criteria. Safety indicators focused on late radiotherapy toxicity and the incidence of grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG. The differences in the incidence of grade 3 and 4 adverse events were compared between the experimental group and the control group. Secondary study endpoint: The differences in 2-year disease-free survival (DFS), regional relapse-free survival (RRFS), distant metastasis free survival (DMFS), safety and adverse events were compared. Safety evaluation NCI-CTC AE 5.0 standard was used to evaluate the acute safety index of radiotherapy, and RTOG late-stage damage evaluation standard was used to evaluate the late-stage safety index of radiotherapy. 4) Exploratory goals The influence of prognostic laboratory indicators, clinical risk factors were analyzed. To explore the factors that influence the efficacy of radiotherapy after pCR immunotherapy.

Radiotherapy for advanced-stage head and neck squamous cell carcinoma (HNSCC) results in an unfavorable 5-year overall survival of 40%, and there is a strong biological rationale for improving outcome by combinatorial treatment with immunotherapy. However, also immunosuppressive effects of radiotherapy have been reported and recently a randomized phase-III trial failed to show any survival benefit following the combination of a PD-L1 inhibitor with chemoradiotherapy. The hypothesis is that the combination of these individually effective treatments failed because of radiation-induced lymphodepletion and that the key therefore lies in reforming conventional radiotherapy, which typically consists of large lymphotoxic radiation fields of 35 fractions. By integrating modern radiobiology and individually established innovative radiotherapy concepts, the patient's immune system could be maximally retained. This will be achieved by 1) increasing the radiation dose per fraction so that the total number of fractions can be reduced (HYpofractionation), 2) by redistributing the radiation dose towards a higher peak dose within the tumor center and a lowered elective-field dose (Dose-redistribution) and 3) by using RAdiotherapy with protons instead of photons (HYDRA). The objectives of this study are to determine the safety of HYDRA with protons and photons by conducting two parallel phase-I trials. HYDRA's efficacy will be compared to standard of care (SOC). The immune effects of HYDRA-protons will be evaluated by longitudinal immune profiling and compared to HYDRA-photons and SOC (with protons and photons). There will be a specific focus on actionable immune targets and their temporal patterns that can be tested in future hypofractionated-immunotherapy combination trials. This trial therefore is an important step towards future personalized immuno-radiotherapy combinations with the ultimate goal to improve survival for patients with HNSCC.

This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.

The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab. The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development. The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose. It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.