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Neoplasm Metastasis clinical trials

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NCT ID: NCT06003998 Recruiting - Colorectal Cancer Clinical Trials

Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

INTERACT-II
Start date: December 27, 2022
Phase: Phase 2
Study type: Interventional

The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progression free survival in patients with unresectable colorectal peritoneal metastases. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with unresectable colorectal peritoneal metastases. Secondary objectives are to assess the progression-free survival, toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 + bevacizumab.

NCT ID: NCT06001528 Recruiting - Breast Cancer Clinical Trials

Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer

Start date: January 1, 2021
Phase:
Study type: Observational

Breast cancer is a malignant tumor with the highest morbidity and mortality among women worldwide. Accurate staging of axillary lymph nodes is critical for metastatic assessment and decisions regarding treatment modalities in breast cancer patient. Among patients who underwent sentinel lymph node biopsy, about 70 % of the patients had negative pathological results and in other words, these 70 % of the patients received unnecessary surgery. At present, imaging and pathological diagnosis is the main measure of lymph node metastasis in breast cancer. However, limitations remained. Artificial intelligence, including deep learning and machine learning algorithms, has emerged as a possible technique, which can make a more accuracy prediction through machine-based collection, learning and processing of previous information, especially in radiology and pathology-based diagnosis. With the intensification of the concept of precision medicine and the development of non-invasive technology, the investigators intend to use the artificial intelligence technology to develop a serum and tissue-based predictive model for sentinel lymph node metastasis diagnosis combined with imaging and pathological information, providing specific, efficient and non-invasive biological indicators for the monitoring and early intervention of lymph node metastasis in patient with breast cancer. Therefore, the investigators retrospectively include serum samples from early breast cancer patients undergoing sentinel lymph node biopsy, including a discovery cohort and a modeling cohort. Metabolites were detected and screened in the discovery cohort and then as the target metabolites for targeted detection in the modeling cohort. Combined with preoperative imaging and pathological information, a prediction model of breast cancer sentinel lymph node metastasis based on serum metabolites would be established. Subsequently, multi-center breast cancer patients will prospectively be included to verify the accuracy and stability of the model.

NCT ID: NCT06001255 Recruiting - Clinical trials for Metastasis Castration Resistant Prostate Cancer(mCRPC)

ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Start date: January 18, 2024
Phase: Phase 2
Study type: Interventional

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.

NCT ID: NCT05987644 Recruiting - Lung Cancer Clinical Trials

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

DURABLE
Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.

NCT ID: NCT05977803 Recruiting - Brain Metastases Clinical Trials

Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin

ACROP
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to determine whether the use of the CEST sequence would have diagnostic performance equivalent to the reference method of T2* infusion with contrast injection in the diagnosis of radionecrosis of lung cancer brain metastases.

NCT ID: NCT05970913 Recruiting - Clinical trials for Non Small Cell Lung Cancer

PET-CT Predicting Segement Specific Lymph Nodes Metastasis

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

This study is a multicenter prospective clinical study that aims to evaluate the predictive value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in patients with non-small cell lung cancer. During surgery, all patients underwent systematic mediastinal lymph node dissection. The final pathological results were used to assess the predictive value of PET-CT for segment-specific lymph node metastasis.

NCT ID: NCT05967143 Recruiting - Clinical trials for Unresectable Hepatocellular Carcinoma (HCC)

Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

SIRtain
Start date: June 19, 2023
Phase:
Study type: Observational [Patient Registry]

This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

NCT ID: NCT05965817 Recruiting - Colorectal Cancer Clinical Trials

Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN

FOCUS GREEN
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.

NCT ID: NCT05961644 Recruiting - Multiple Sclerosis Clinical Trials

Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).

CLASP-MS
Start date: October 3, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of subcutaneously administered cladribine versus placebo to stop inflammation and treat disease progression of non-active secondary progressive multiple sclerosis. Multiple sclerosis is an inflammatory disease of the central nervous system. In most patients, it starts with a relapsing course (RMS) which is caused by acute inflammatory lesions in the brain and spinal cord. RMS transforms at later stages into progressive disease (secondary progressive MS). Currently approved disease-modifying treatments are effective in reducing clinical relapses and brain and spinal lesions visible in MR, but they perform poorly in preventing disease progression and overall disability accumulation. The growing evidence shows that disease progression partially depends on chronic inflammation present in the CNS. Drugs, which may cross the blood-brain barrier and reach inflammatory cells residing in the CNS might be effective in this stage of the disease. Cladribine is one of the DMT approved for RMS. It is a synthetic purine analog with selective lymphocyte toxicity, which enter the CNS and is found in cerebrospinal fluid. In patients treated with cladribine, the oligoclonal bands tend to disappear proving that neuroinflammation is diminished. The participants of this clinical trial with the later non-active stage of MS are enrolled to be treated with cladribine subcutaneously or a non-active comparator (placebo) for 6 months and followed for the next 2 years, with an MRI scan and clinical evaluation every 6 months. The main questions it aims to answer are if in the non-active stage of MS cladribine is potent to lessen brain volume loss and if it is potent to attenuate inflammation in the CNS.

NCT ID: NCT05948813 Recruiting - NSCLC Clinical Trials

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

Start date: August 17, 2023
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.