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Neoadjuvant Chemotherapy clinical trials

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NCT ID: NCT06281210 Recruiting - Breast Cancer Clinical Trials

Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

BETTY-CRASY
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

NCT ID: NCT06220214 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Start date: March 23, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. Participation may last up to 18 weeks. Study procedures for this research are: - Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. - Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent - Let the research team record information from your medical record related to your condition and the treatment you receive. - Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

NCT ID: NCT06155305 Recruiting - Breast Cancer Clinical Trials

Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

ONAC
Start date: December 6, 2023
Phase:
Study type: Observational

Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.

NCT ID: NCT05910710 Recruiting - Clinical trials for Triple Negative Breast Cancer

Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Start date: March 2, 2023
Phase:
Study type: Observational [Patient Registry]

It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer. (Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)

NCT ID: NCT05901779 Recruiting - Gastric Cancer Clinical Trials

Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT. Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.

NCT ID: NCT05617469 Recruiting - Gastric Cancer Clinical Trials

DLCS for Predicting Neoadjuvant Chemotherapy Response

Start date: July 1, 2022
Phase:
Study type: Observational

The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.

NCT ID: NCT05554276 Recruiting - Cervical Cancer Clinical Trials

Neoadjuvant Chemotherapy Combined With PD-1 + Radical Radiotherapy in Locally Advanced Cervical Cancer

PD-1
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.

NCT ID: NCT05522985 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: November 7, 2021
Phase: Phase 2
Study type: Interventional

The objective of research is to evaluate the efficacy and safety of treprizumab injection combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (treprizumab injection combined with AP protocol) and the control group (TP protocol); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.

NCT ID: NCT05367206 Recruiting - Cervical Cancer Clinical Trials

Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

N6C
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma >4 cm in greatest dimension and/or lymph node >2cm in short axis.

NCT ID: NCT05246020 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)

NHIPEC
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.