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Neoplasm Metastasis clinical trials

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NCT ID: NCT04233021 Active, not recruiting - Brain Metastases Clinical Trials

Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

ORBITAL
Start date: July 16, 2020
Phase: Phase 2
Study type: Interventional

Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment. In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication. Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.

NCT ID: NCT04230239 Completed - Clinical trials for Newly Diagnosed Secondary or High Risk AML

Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia

LAMVYX
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

This protocol corresponds to a prospective, multicentre, open label, phase II study designed to evaluate the efficacy of CPX-351 in elderly patients with secondary or high-risk AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a single arm group. Patients will be enrolled at diagnosis to follow the treatment arm. After that will start induction chemotherapy with CPX-351 regimen (14 days maximum screening period). Once a patient have been evaluated for response and recovered from major complications, he/she will start second course (consolidation 1), unless the bone marrow and peripheral blood assessment is showing less than a complete response, then a second induction may be offered. If a CR or CRi is obtained after the second induction course, patients will start the third course after a rest and recovery period. Patients aged between 60 and 65 years old are recommended to undergo an allo-SCT after first consolidation if they are considered fit for this procedure and they have a full matched related or unrelated donor. Patients aged between 65 and 70 years old can be proposed for an allo-SCT in CR/CRi if they have a composite HSCT co-morbidity index /age less than 4 and a suitable fully matched related donor. In patients over 70 years old, an allo-SCT in first CR should be avoided although the decision should be taken on an individual basis. Patients with CR/CRi who are not considered for an allo-SCT, will follow 6 maintenance cycles with modified courses of CPX-351 schedule. Patients showing unacceptable toxicity along all therapeutic phases that, in consideration of the investigator, will be prematurely discontinued. All patients will be followed-up for survival. The study will be analyzed on an intention to treat basis. Bone marrow and response assessments will be done after each induction and consolidation course, and every 3 months during the first 12 months after starting maintenance therapy. Patients will be followed-up for a minimum period of 1 year after the enrolment of the last patient. Additionally, after the end of the trial, patients will be followed-up for 2 years in order to verify survival and the evolution of the disease. Study design allows a maximum of 59 patients.

NCT ID: NCT04230018 Recruiting - Clinical trials for Metastatic Colorectal Cancer

The Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer

Start date: December 28, 2018
Phase:
Study type: Observational

The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.

NCT ID: NCT04222114 Recruiting - Stomach Neoplasms Clinical Trials

Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis

Start date: October 6, 2020
Phase: Phase 3
Study type: Interventional

A total of 297 subjects are estimated to enroll in the study, with 15 eligible subjects enrolled in the 1st stage at most and 282 evaluable subjects in the 2nd stage. All subjects are adult patients with age over 18-year-old; they must be diagnosed with recurrent or metastatic gastric cancer with peritoneal metastasis at the time of enrollment; and failed at least prior two standard systemic anti-cancer therapies for recurrent or metastatic gastric cancer, before enrollment. In the first stage, pharmacokinetic characteristics and preliminary safety of catumaxomab will be explored in Asian patients with gastric cancer ; in Cohort A, the enrolled subjects will receive the first infusion at 10μg on day 1, which will be increased to 20 μg, 50 μg and 150 μg on days 4, 8 and 11, respectively. 42 days are defined as a cycle. From the second cycle, catumaxomab will be changed to 20 μg, 50 μg, 150 μg on days 1, 4, 8 respectively. In Cohort B, 28 days are defined as a cycle. It is estimated to enroll 6 subjects in each cohort first. In the second stage, approximate 282 subjects who meet the enrollment criteria are randomized into either catumaxomab infusion group (catumaxomab group) or treatment of investigator choice group (IC group), at a ratio of 2:1. Subjects at the first and second stages will continue the treatment until one of the following conditions occurs:1)Significant progression of tumor lesions, including but not limited to peritoneal metastases lesions and/or ascites; 2)Intolerable toxicity; 3)The investigator believes that patients need to withdraw from the study and receive other treatment;4)death;5)Withdrawal of informed consent.

NCT ID: NCT04218617 Recruiting - Spine Metastases Clinical Trials

Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Start date: February 7, 2020
Phase: Phase 2
Study type: Interventional

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

NCT ID: NCT04213222 Not yet recruiting - Rectal Cancer Clinical Trials

Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases

ROBOT
Start date: October 2020
Phase:
Study type: Observational

Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.

NCT ID: NCT04213170 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Sintilimab Combined With Bevacizumab for Brain Metastases From Non-small Cell Lung Cancer

Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

This is a prospective phase II clinical study to assess the efficacy of Sintilimab combined with Bevacizumab for driving gene-negative, asymptomatic brain metastases from non-small cell lung cancer by intracranial ORR(iORR),also iPFS,ORR and PFS.The safety and tolerability is evaluated as well.

NCT ID: NCT04211090 Active, not recruiting - Brain Metastases Clinical Trials

Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC

CAP-BRAIN
Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity

NCT ID: NCT04208958 Completed - Colorectal Cancer Clinical Trials

Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

ConsortiumIO
Start date: January 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

NCT ID: NCT04206358 Recruiting - Melanoma Clinical Trials

Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma

Start date: May 13, 2019
Phase: Phase 1
Study type: Interventional

This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma. This study is planned to enroll approximately 30 patients with Stage IV (M1c) Liver Metastasis from Melanoma who meet protocol requirements. This study is a single-arm clinical trial. All participator will be given OrienX010 in combination with JS001. JS001 injection: 3 mg/kg, IV infusion: Once every 2 weeks ; OrienX010: Maximum injection volume 8 × 10^8 pfu, intratumoral injection: Once every 2 weeks. Treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), intolerable AE, or withdrew informed consent or meet other criteria of discontinuation. For patients who have stopped the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event.