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Neoadjuvant Therapy clinical trials

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NCT ID: NCT05964595 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC). The main questions it aims to answer are: - If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC? - If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy. There is not a comparison group in our study.

NCT ID: NCT05906407 Recruiting - Neoadjuvant Therapy Clinical Trials

COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer

COGNITION
Start date: April 19, 2019
Phase:
Study type: Observational

The COGNITION diagnostic platform elucidates the biomarker profile of neoadjuvant chemotherapy-resistant residual bulk tumors in high risk early breast cancer patients. The major goal is to provide a framework for genomic profiling, which serves as infrastructure for systematic biomarker-screening and -stratification for concise therapy-arm allocation in the interventional clinical phase II trial COGNITION-GUIDE (NCT05332561). In patients, who display a poor response to standard-of-care neoadjuvant chemotherapy, tissue samples before and after neoadjuvant therapy are subjected together with blood samples to comprehensive genomic profiling to identify patients potentially benefiting from biomarker-guided interventions in COGNITION-GUIDE. Samples not required for standard-of-care clinical procedures or genomic profiling are systematically collected in a dedicated bio-repository to fuel translational scientific companion programs. The continuously growing comprehensive database serves as an integrative resource for systematic, prospective multidimensional data collection (clinical records, biomaterial, genomic data). In summary, the overarching goal is to generate a precision oncology platform i) to identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) to couple the observational, diagnostic registry platform to the independent, biomarker-stratified clinical therapy trial COGNITION-GUIDE.

NCT ID: NCT05882513 Recruiting - NSCLC Clinical Trials

Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer

Start date: May 16, 2023
Phase: Phase 2
Study type: Interventional

China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.

NCT ID: NCT05861635 Recruiting - Breast Cancer Clinical Trials

The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

NCT ID: NCT05775796 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)

Start date: March 15, 2023
Phase: Phase 2
Study type: Interventional

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC).

NCT ID: NCT05659251 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

NCT ID: NCT05512468 Recruiting - Breast Cancer Clinical Trials

Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

NCT ID: NCT05406999 Recruiting - Neoadjuvant Therapy Clinical Trials

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Start date: February 1, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

NCT ID: NCT05376722 Recruiting - Neoadjuvant Therapy Clinical Trials

A Study of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of Prostate Cancer

Start date: February 22, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy

NCT ID: NCT05371197 Recruiting - Colorectal Cancer Clinical Trials

Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which accounts for approximately 15% of all CRC patients, and can not benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and thus lead to much worse prognosis than that of mismatch repair-proficient (pMMR)/ microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in "N Engl J Med" showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Another study (ClinicalTrials.gov, NCT03926338) which investigating the effect of neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, on mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer. The result revealed that all 34 patients had an R0 resection. 15 of 17 patients (88%) in the toripalimab plus celecoxib group and 11 of 17 patients (65%) in the toripalimab monotherapy group had a pathological complete response. In theory, anti-PD-L1 drugs should have fewer immune side-effects than anti-PD-1 drugs. However, there are no reports of anti-PD-L1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to investigate the efficacy and safety of anti-PD-L1 monoclonal antibody (Envafolimab) as neoadjuvant immuntherapy for resectable local advanced colorectal cancer patient with the dMMR/MSI-H.