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Neoplasms clinical trials

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NCT ID: NCT05277402 Completed - Clinical trials for Advanced/Metastatic Solid Tumors

ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

Start date: February 9, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.

NCT ID: NCT05270655 Completed - Depression Clinical Trials

Cognitive-behavioural Intervention for Anxiety, Depression and Quality of Life Among Children Receiving Chemotherapy.

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

The diagnosis and treatment of paediatric cancer is the most stressful experience for children and their families. Nearly all paediatric cancer patients are presented with at least one psychosocial problem, of which, anxiety and depression often coexist and are most frequently reported. Poorly managed anxiety and depression causes emotional and behavioural problems, impairs relationships and functioning, decreases adhere to treatment, increases the burden of symptoms and significantly impacts quality of life and prognosis. Despite the high rates and negative impacts of anxiety and depression in paediatric oncology, they are poorly managed. Thus, to mitigate the burden of anxiety, depression and impaired quality of life, an age-appropriate cognitive-behavioural intervention shows promise when incorporated with the existing pharmacologic interventions. This study aims to test how effective cognitive-behavioural intervention is to improve anxiety, depression and quality of life of children during chemotherapy. The study will be conducted in two hospitals in Ethiopia and include 8-18-year-old children with haematological cancer receiving chemotherapy, able to communicate with the local language, Amharic, able to provide parental consent and child assent, and without history of developmental, psychological, psychiatric, hearing or speech problems. The study will enroll up to 80 participants and randomise them into two groups, one group will receive a cognitive-behavioural intervention and the the other group will receive the usual psychosocial care provided by staff nurses. Participants in the cognitive-behavioural intervention group will receive five sessions of individual face to face cognitive-behavioural intervention. Each session will last approximately 30-35 minutes a week and supplemented by home-based practices. This study will use different intervention delivery strategies including psychoeducation, guided discovery or Socratic questioning, discussion, drawing, painting or writing, and play depending on the content of each session and maturity of the child. The levels of anxiety, depression and quality of life will be measured before the intervention, after the intervention and one month after completion of the intervention in both groups.

NCT ID: NCT05265221 Completed - Gastric Neoplasm Clinical Trials

Learning Curve for Gastric Endoscopic Submucosal Dissection

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

Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide. ESD is relatively difficult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.

NCT ID: NCT05249127 Completed - Clinical trials for Biochemical Recurrence of Malignant Neoplasm of Prostate

64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

COBRA
Start date: April 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

NCT ID: NCT05246111 Completed - Clinical trials for Advanced Solid Tumor

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Start date: February 15, 2022
Phase: Phase 1
Study type: Interventional

The study will be conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study is to provide a quantitative characterization of the mass balance, rates and routes of elimination, and metabolic pathways after a single intravenous administration of [14C]berzosertib. The purpose of Period 2 is to assess safety and efficacy of berzosertib in combination with topotecan.

NCT ID: NCT05235750 Completed - Neoplasms Clinical Trials

Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

Start date: May 27, 2022
Phase: N/A
Study type: Interventional

A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QOL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the 12-item Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be referred and enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QOL.

NCT ID: NCT05231746 Completed - Clinical trials for Advanced Solid Tumor

A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)

Start date: April 18, 2022
Phase: Phase 1
Study type: Interventional

The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.

NCT ID: NCT05230290 Completed - Solid Tumor Clinical Trials

Clinical Study of KD6001 in Advanced Solid Tumours

Start date: September 10, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and clinical activity of KD6001 as treatment for participants with advanced solid tumours.

NCT ID: NCT05211271 Completed - Cervical Neoplasia Clinical Trials

Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

NCT ID: NCT05187858 Completed - Clinical trials for NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Start date: September 22, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.