Phase 2 Liver Cancer 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 phases:

• People who have colorectal cancer that has spread to other parts of the body, with tumors that can be measured on scans using standard criteria
• People whose original bowel tumor has already been surgically removed, or whose original tumor is not causing any symptoms
• People who had their most recent body scan no more than 4 weeks before the planned procedure in this study
• People aged 18 years or older
• People who are generally well enough to carry out light activity and care for themselves (a standard medical fitness scale rates this as 0 or 1 out of 5)
• People with a life expectancy of at least 3 months at the time of joining the trial
• People whose bone marrow, liver, and kidney are functioning well enough, based on blood tests done within 7 days before joining
• People who have provided written agreement to take part

Additional criteria for Phase 1 only:

• People whose cancer has either grown or stayed stable on scans after receiving at least one round of standard cancer treatment, or who had to stop treatment due to side effects, or who chose not to continue, or who are taking a break from treatment
• People who have at least 2 liver tumors (from the spread of colorectal cancer) that are suitable for a heat-based treatment called microwave ablation, each between 1 cm and 3 cm in size

Additional criteria for Phase 2, Part 1 only:

• People who have between one and three liver tumors from colorectal cancer, each no larger than 3 cm, that are suitable for microwave ablation with the aim of removing all cancer
• People whose any additional liver tumors that cannot be treated with ablation could still be surgically removed, with no more than 10 such additional tumors

Additional criteria for Phase 2, Part 2 only:

• People whose cancer has spread mainly or only to the liver, with no more than 5 tumors outside the liver across no more than 2 different organs
• People who have at least 2 liver tumors from colorectal cancer, with at least one suitable for the ablation treatments used in this study
• People where at least half of the liver tumors (by number and estimated size) are suitable for ablation, with no more than 4 tumors assigned for treatment and at least one tumor left untreated
• People whose liver tumors earmarked for treatment are no larger than 3 cm
• People where any liver tumor is no larger than 5 cm at the time of joining
• People whose cancer outside the liver is limited to the lungs and lymph nodes, with those tumors no larger than 3 cm at the time of joining
• People whose cancer has been confirmed as progressing on scans after standard cancer treatment, or who had to stop treatment due to side effects, or who chose not to continue

Who may not be able to join:

Applies to all phases:

• People with poor liver function, including signs of high blood pressure in the liver's main vein, or abnormal blood clotting or liver enzyme levels (confirm with trial site for specific values)
• People with poor kidney function, based on a standard measure of kidney filtering ability falling below a certain level (confirm with trial site)
• People with an active autoimmune disease that requires treatment with more than 10 mg of prednisolone per day, or other immune-suppressing medicines such as methotrexate
• People with substance use issues, or medical, psychological, or social circumstances that could affect their participation or the reliability of results
• People with a known allergic reaction to shellfish, crabs, crustaceans, or any component of the trial treatment
• People with a known history of HIV, or an active Hepatitis B or Hepatitis C infection
• People with a significant uncontrolled infection that requires antibiotics
• People who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment
• People with a known allergy to contrast dye used in scans that cannot be safely managed
• People with any unstable health condition that could affect their safety or ability to complete the study
• People who have had major surgery or radiation therapy within 3 weeks before the planned study procedure (or within 7 days for a single palliative radiation treatment)
• People who have received systemic (whole-body) cancer treatment within 4 weeks before the planned study procedure
• People who still have any ongoing side effects (grade 1 or higher) from previous treatments at the time of joining

Phase 2, Part 1 only:

• People for whom fully removing all cancer would not be feasible or safe (for example, if not enough healthy liver would remain after surgery)
• People who have cancer spread to areas outside the liver other than one single lung tumor that could be treated locally
• People who have previously had surgery or any local ablation treatment for liver tumors from colorectal cancer

Phase 2, Part 2 only:

• People who have any liver tumor measuring 5 cm or more at the time of joining (if a tumor grows beyond this size after joining but before the procedure starts, this would not automatically exclude the person — confirm with trial site)
• People who have lung or lymph node tumors measuring 3 cm or more at the time of joining (same note as above regarding size changes after joining)
• People who have cancer spread to any organ other than the liver, lungs, or lymph nodes

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