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Neoplasm Metastasis clinical trials

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NCT ID: NCT05813522 Enrolling by invitation - Clinical trials for Non Small Cell Lung Cancer

Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC

Start date: April 15, 2022
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation. Participants will be treated with 160mg Furmonertinib daily and tumor evaluation will be performed every 6-8 weeks. The participants' blood and cerebrospinal fluid samples will be collected three times during the study for ctDNA detection.

NCT ID: NCT05812534 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Study of Cadonilimab Combined With Bevacizumab and Chemotherapy for Advanced Nonsquamous Non-small Cell Lung Cancer Patients With Untreated Brain Metastases

CBC
Start date: December 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the efficacy and safety of Cadonilimab combined with bevacizumab and chemotherapy for advanced non-squamous NSCLC with untreated brain metastases. Cadonilimab is a bispecific antibody (BsAb), which can bind PD-1 and CTLA-4 at the same time with high affinity. It is a new tumor immunotherapy drug with tetravalent structure and short half-life. It has shown less toxicity than anti-PD-1 and anti-CTLA-4 antibodies in monkey toxicity studies. These characteristics make the application of Cadonilimab in tumor subjects may have better efficacy and safety. AK104-207 is an open, multicenter, phase Ib/II clinical study, which aims to evaluate the effectiveness and safety of Cadonilimab combined with chemotherapy as the first-line treatment for locally advanced or metastatic non-small cell lung cancer that cannot be operated and cannot receive radical concurrent/sequential radiotherapy and chemotherapy. As of August 1, 2022, 19 subjects who can evaluate non-squamous NSCLC (cohort B), ORR is 63.2%, DCR is 100%, median PFS is 13.34 months (7.36, NE), median OS is not reached, and 12-month OS rate is 76.0% (95% CI 48.0-90.3). In PD-L1 positive patients (n=9), ORR was 55.6% and DCR was 100%. In PD-L1 negative patients (n=7), ORR was 85.7% and DCR was 100%. In view of the early curative effect of Cadonilimab in NSCLC single drug or combination therapy and the encouraging research results of PD-1 inhibitor combined with CTLA-4 double immune combination therapy, it is expected that Cadonilimab combined with bevacizumab and chemotherapy will achieve good curative effect in NSCLC patients with brain metastasis.

NCT ID: NCT05810350 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Aumolertinib Combined Intrathecal Chemotherapy for Leptomeningeal Metastasis From EGFR-Mutated NSCLC and Prognostic Value of Dynamic Changes in cfDNA Profiles

Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, open-label, single-arm clinical trial. The aim of this study is to evaluate the efficacy and safety of almonertinib and intrathecal chemotherapy in patients with advanced EGFR mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) and leptomeningeal metastasis, and to explore the predictive value of dynamic changes of cfDNA in cerebrospinal fluid for efficacy and prognosis. A total of 40 subjects who met the inclusion criteria were enrolled in the study and received almonertinib (165mg, oral, once a day) combined with intrathecal infusion. Before and after treatment, cerebrospinal fluid was extracted for cfDNA detection by a 49 gene detection panel. Treatment continued until disease progression or other discontinuation criteria were met. In addition, the subjects received regular hematological and imaging examinations to evaluate the condition. Finally, through data analysis, the progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), duration of response (DoR), and overall survival (OS) of patients with EGFR mutation-positive advanced NSCLC and leptomeningeal metastasis who received almonertinib combined with intrathecal infusion chemotherapy were evaluated. The dynamic changes of cfDNA in cerebrospinal fluid before and after treatment were explored and the correlation between the dynamic changes of cfDNA in cerebrospinal fluid and the therapeutic effect was explored.

NCT ID: NCT05808998 Not yet recruiting - Radiation Therapy Clinical Trials

A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy

SM-SBRT
Start date: April 1, 2023
Phase:
Study type: Observational

A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.

NCT ID: NCT05808790 Not yet recruiting - Clinical trials for Colorectal Cancer Metastatic

Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

COPPER
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

COPPER is an international, multicenter, parallel-arm, phase III randomized controlled trial comparing two local treatment strategies (SABR or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases

NCT ID: NCT05807893 Not yet recruiting - Brain Metastases Clinical Trials

Study to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain Metastases

SUPER BRAIN
Start date: April 14, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A multicenter, single-arm, open study to evaluate the safety and efficacy of Serplulimab in combination with bevacizumab and first-line chemotherapy in driver negative non-squamous NSCLC patients with brain metastases

NCT ID: NCT05805631 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

Leptomeningeal metastasis (LM) is a complication of advanced non-small cell lung cancer (NSCLC). The incidence of LM in NSCLC patients is around 3-5 %, reaching 9.4 % of those with an epidermal growth factor receptor (EGFR) mutation. Generally, the efficacy of systemic treatment for LM is limited due to the blood-brain barrier. Osimertinib has a high central nervous system penetration rate, making it the preferred first-line treatment for EGFR-mutant NSCLC. Previous studies indicated that osimertinib had shown promising efficacy in pretreated patients harboring EGFR mutations and LM. However, intracranial disease progression eventually develops, and the prognosis of patients with LM progression after osimertinib is poor. Recently, intrathecal chemotherapy with pemetrexed (IP) was reported to be an alternative treatment in patients with NSCLC and LM. The results from a phase I/II trial examining the efficacy and safety of IP in patients with EGFR-mutant NSCLC after the failure of previous TKI, and 83% of study enrollees received osimertinib before IP. The clinical response rate was 84.6%, and the median overall survival was 9.0 months. Despite initial promising efficacy, further trials are needed to verify these results. Therefore, the investigators plan to conduct a prospective study to examine the safety and effectiveness of IP combined with EGFR-TKI for patients with EGFR mutant NSCLC after osimertinib failure.

NCT ID: NCT05800275 Recruiting - Clinical trials for Leptomeningeal Metastasis

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

ETIC-LM
Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.

NCT ID: NCT05797077 Recruiting - Colorectal Cancer Clinical Trials

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Start date: February 20, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

NCT ID: NCT05794971 Recruiting - Clinical trials for Colorectal Cancer Liver Metastases

Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases

RIDER
Start date: June 10, 2023
Phase: Phase 3
Study type: Interventional

This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.