Trials on Stomach, bowel and glands

JADE / IOM-100425Recruiting

Liver Cancer Registry Platform

Liver cancer is often diagnosed at a late stage. Various treatments are available for liver cancer, but there has been a lack of structured treatment data from clinical practice to date. The goal of the JADE study is to establish a Germany-wide database for patients with liver cancer in order to collect standardized data on the disease and treatment processes and to improve treatment. Women and men aged 18 and older with liver cancer who are not receiving “best supportive care” are eligible to participate in the study.

18 years and older · First line

FIRE-4 / AIO-KRK-0114 Recruiting

FIRE-4

The FIRE-4 study is investigating whether re-treatment with the anti-EGFR antibody cetuximab in third-line therapy results in a better response than another chemotherapy regimen.

18 years and older · Relapsed / refractory · Phase III

FIRE-8Recruiting

Comparison of First-Line Therapy for Advanced Colorectal Cancer: Trifluridine/Tipiracil Combined with Panitumumab Versus Trifluridine/Tipiracil Combined with Bevacizumab

Patients with metastatic colorectal cancer typically receive intensive chemotherapy—usually in combination with immunotherapy—as their standard treatment. If they are not fit enough for this treatment, they are usually given a milder chemotherapy regimen consisting of capecitabine in combination with bevacizumab. The goal of the FIRE-8 study is to evaluate the safety and efficacy of the trifluridine/tipiracil chemotherapy regimen as a first-line treatment for patients with lower fitness levels and to compare whether a combination with the antibody panitumumab or bevacizumab is more effective. Men and women aged 18 and older who have metastatic colorectal cancer that can no longer be surgically removed are eligible to participate in the study.

18 years and older · First line · Phase II

MET-RegisterRecruiting

Registry for Malignant Endocrine Tumors in Children and Adolescents

The treatment of malignant endocrine tumors in children and adolescents poses a challenge, as there is currently very little consistently collected long-term data available for these rare diseases. The goal of the MET Registry is to improve the care of children and adolescents with malignant endocrine tumors by centrally recording the course of treatment and the disease, as well as long-term outcomes. Children and adolescents up to age 18 with malignant endocrine tumors are eligible to participate in this registry.

0–18 years · First line · Phase IV

AAV-AH-OI-01Recruiting

Laboratory tests to identify suitable gene vectors for targeted tumor gene therapy in colorectal and kidney cancer

Gene therapy is considered an innovative treatment approach designed to specifically modify tumor cells genetically; however, the gene delivery vehicles—known as vectors—used in this therapy have so far often been unable to reliably distinguish between healthy and diseased cells. The goal of the AAV-AH-OI-01 study is to investigate which AAV vectors are particularly effective at reaching tumor cells in colorectal and renal cell carcinomas, in order to make the treatment more targeted and better tolerated in the future. Eligible participants include women and men aged 18 and older with untreated colorectal cancer (colon carcinoma) or renal cell carcinoma who are scheduled to undergo surgery to remove the tumor. The study does not affect the actual treatment; instead, it tests the vectors exclusively on tumor tissue removed after surgery.

18 years and older · First line

IMMUWHYRecruiting

A Study of the Efficacy of a New Treatment Option for Advanced Bile Duct Cancer of the Liver Using Immunotherapy and Targeted Radiation Therapy

The standard treatment for advanced bile duct cancer involves radiation therapy to the tumor. There is evidence that adding immunotherapy with a checkpoint inhibitor could provide additional survival benefits. The goal of the IMMUWHY study is to investigate the effect of combining radiation therapy with subsequent administration of a checkpoint inhibitor—either durvalumab alone or in combination with tremelimumab. Men and women aged 18 and older with locally advanced, incurable intrahepatic bile duct cancer are eligible to participate in the study. Metastases may already be present, but their number must be limited and the disease must be stable overall.

18–99 years · Relapsed / refractory · Phase II

INFORM2 NivEntRecruiting

A single-arm study of the treatment of high-risk tumors with nivolumab and entinostat in children and adolescents

So-called high-risk tumors often progress very rapidly despite optimal treatment and are usually resistant to standard therapies. Immunotherapies and targeted drugs, such as the study drugs nivolumab and entinostat, offer new hope. Previous studies suggest that this combination may inhibit tumor growth in tumors with specific genetic characteristics. The goal of the INFORM2 study is to to investigate the efficacy of the combination therapy of nivolumab and entinostat in children and adolescents with treatment-resistant or recurrent high-risk tumors, and to compare whether the efficacy of this combination therapy differs in tumors with specific genetic alterations compared to those without these characteristics. Patients between the ages of 2 and 21 with a brain tumor or solid tumor classified as high-risk are eligible to participate. The tumor must either have a myc(n) amplification, a high mutation burden, or high PD-L1 expression—or none of these characteristics.

2–21 years · Relapsed / refractory · Phase I/II

IMA401-101Recruiting

Study to Evaluate the Safety, Tolerability, and Efficacy of a New Drug (Name: IMA401) in Patients with Recurrent or Uncontrolled Breast Cancer

Solid tumors are cancers that develop in organs such as the lungs, liver, or breast. When these tumors progress and no longer respond to standard therapies, novel drugs may be considered as additional treatment options. The goal of the IMA401-TCER study is to investigate the safety and tolerability of the new drug IMA401, which specifically targets certain cancer cells. Eligible participants include women and men aged 18 and older with advanced or metastatic solid tumors, including breast cancer, that no longer respond to standard therapies and exhibit a specific genetic profile (HLA-positive and MAGEA4/8).

18 years and older · Relapsed / refractory · Phase I

OncoPhysRecruiting

OncoPhys Study: Investigating Physical Activity in Cancer Patients Using Questionnaires, Activity Trackers, and Patients

Physical activity can improve treatment outcomes for cancer patients. However, the accuracy of methods used to measure physical activity can vary greatly. The goal of the OncoPhys study is to compare the results of physical activity measurements obtained using a questionnaire and an activity tracker. Women and men aged 18 and older with lymphoma, pancreatic cancer, or colorectal cancer are eligible to participate in this study.

18 years and older

EVICTION Active, not recruiting

Clinical Trial for Recurrent or Inadequately Treated Breast Cancer: Is the novel drug ICT01 an effective option as monotherapy or in combination with pembrolizumab?

New treatment options are constantly being sought for advanced cancer. This also applies to breast cancer. A novel antibody (designated ICT01) could represent a new treatment option. The goal of the EVICTION study is to investigate the safety, tolerability, and efficacy of the new drug ICT01, either alone or in combination with pembrolizumab, a checkpoint inhibitor. Women and men aged 18 and older with breast cancer or another type of cancer are eligible to participate if prior treatment has been unsuccessful or if the disease has become active again (recurrence).

18 years and older · Relapsed / refractory · Phase I/II

Trials on Stomach, bowel and glands37