Phase 2 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Criteria that apply to all groups:

• People who have been diagnosed with one of the following cancers: metastatic colorectal cancer (bowel cancer that has spread), intrahepatic cholangiocarcinoma (a type of bile duct cancer inside the liver), or adrenocortical carcinoma (a cancer of the adrenal gland) that has spread mainly to the liver.
• People whose cancer specialist has recommended and is planning to oversee one of the standard chemotherapy treatment plans used for their specific cancer type, starting no sooner than 28 days after the study treatment begins.
• People aged 18 or older.
• People who are able to become pregnant must have a negative pregnancy test at the start of the study.
• All participants must agree to use highly effective contraception during the study and for either 3 months (for those who could father a child) or 6 months (for those who could become pregnant) after finishing the study treatment.
• People who are currently breastfeeding must agree to stop before joining.
• People whose blood vessel structure in the liver is suitable for placement of a hepatic artery infusion pump (a device used to deliver treatment directly to the liver), as confirmed by a special type of CT scan.
• People who are willing to sign a consent form to take part in the study.
• People living with HIV may be considered, provided their viral load is undetectable.
• People who agree to also participate in a separate tissue collection study (confirm with trial site).
• People whose liver tumours cannot be fully removed or destroyed in a single surgical procedure.

Additional criteria for metastatic colorectal cancer (bowel cancer spread to the liver):

• People who have a confirmed diagnosis of colorectal cancer (bowel cancer) that has spread to the liver.
• People who have measurable tumour(s) in the liver.
• People who have already received a first round of chemotherapy treatment.
• People who are generally well enough to carry out light daily activities (a standard medical fitness scale called ECOG must show a score of 0 or 1).
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning well enough to safely take part (confirm specific values with trial site).

Additional criteria for intrahepatic cholangiocarcinoma (bile duct cancer in the liver):

• People who have a confirmed diagnosis of bile duct cancer that is located within the liver. A tissue sample from a previous biopsy may be used, or a new biopsy may be required.
• People whose cancer has not spread beyond the liver, except possibly to nearby lymph nodes near the liver that could be surgically removed.
• People who have measurable disease on scans.
• People whose cancer is considered not surgically removable at the time of the pre-surgery assessment.
• People who have already received a first round of chemotherapy.
• People who score 0 or 1 on the ECOG fitness scale.
• People whose blood test results show adequate bone marrow, liver, and kidney function (confirm specific values with trial site).

Additional criteria for adrenocortical carcinoma (adrenal gland cancer spread to the liver):

• People who have a confirmed diagnosis of adrenocortical carcinoma.
• People who have already received at least one round of chemotherapy.
• People who have measurable tumour(s) in the liver.
• People who score 0 or 1 on the ECOG fitness scale.
• People whose blood test results show adequate bone marrow, liver, and kidney function (confirm specific values with trial site).

Who may not be able to join:

Criteria that apply to all groups:

• People who are currently taking part in another clinical trial involving an investigational (experimental) treatment.
• People who have previously been treated with rIL-12 (a type of immune-boosting drug being used in this study).
• People with active autoimmune diseases (conditions where the immune system attacks the body) that could get worse with immune-stimulating treatment — though some conditions such as type 1 diabetes, vitiligo, alopecia, psoriasis, or thyroid conditions not requiring immune-suppressing drugs may still be considered (confirm with trial site).
• People who have had an organ transplant that requires ongoing immune-suppressing medication.
• People with a history of, or currently active, inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• People with known allergies or sensitivities to substances similar to the study drugs (including rIL-12, other similar biological medicines, or the drugs FUDR or heparin).
• People with serious heart or blood vessel conditions, including a stroke or heart attack within the past 6 months, unstable chest pain, significant heart failure, or a serious irregular heartbeat requiring medication.
• People with conditions that cause significant damage to healthy (non-tumour) tissue.
• People who have had stomach or upper digestive tract ulcers within the past 6 months.
• People with active reduced blood flow to the bowel.
• People with mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who have had another active cancer in the last 5 years, other than certain skin cancers (basal cell carcinoma) or thyroid cancer.
• People who have previously had radiation treatment to the liver.
• People with an active hepatitis B or C infection.
• People with a significant active or chronic infection, including tuberculosis.
• People with any other condition, lab result abnormality, or insufficient healthy liver tissue that the medical team considers to make participation unsafe or the study results difficult to interpret.

Additional exclusion criteria for metastatic colorectal cancer:

• People with clear evidence on scans of cancer spread to areas other than the bowel (original site) and liver, where liver-directed treatment is unlikely to help — with some exceptions for small, stable lung spots (confirm with trial site).
• People who have had surgery to remove cancer from outside the liver, with a disease-free period of 4 months or less before the study.
• People with a specific genetic tumour result (MSI-high) who still need to be treated with checkpoint inhibitor drugs (a type of immunotherapy).
• People who have previously been treated with the drug FUDR.

Additional exclusion criteria for intrahepatic cholangiocarcinoma:

• People with clear evidence of cancer that has spread to distant parts of the body beyond the liver — with some exceptions for small, stable lung spots (confirm with trial site).
• People who have previously been treated with the drug FUDR.
• People who have a diagnosis of sclerosing cholangitis (a chronic liver/bile duct condition).
• People with clinical signs of high blood pressure in the liver's portal vein system, such as fluid build-up in the abdomen, enlarged veins in the oesophagus, or a blood clot in the portal vein.

Additional exclusion criteria for adrenocortical carcinoma:

• People with clear evidence on scans of cancer spread within the abdomen outside the liver that cannot be fully removed surgically at the time the pump is placed.
• People with clinical signs of high blood pressure in the liver's portal vein system, such as fluid build-up in the abdomen, enlarged veins in the oesophagus, or a blood clot in the portal vein.
• People who have been diagnosed with sclerosing cholangitis.
• People whose lung tumours have grown according to standard measurement criteria in the 3 months before joining the study.
• People with a known DNA mismatch repair mutation who have not yet been treated with a checkpoint inhibitor (a type of immunotherapy) (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.