Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT04451603
Eligibility Criteria:
Inclusion criteria:
Common Inclusion Criteria (Surgical Resection, Y90 Treatment and Systemic Therapy):
* Male and female patients, 21 to 90 years of age at the time of signing of the informed consent form.
* For HCC patients: Diagnosis of HCC confirmed by either 1 of the following 3 criteria:
* AASLD imaging criteria
* Histology/cytology of biopsy or surgically resected tumor tissue samples
* Space occupying lesion in the liver and serum alpha-fetoprotein (AFP) of more than 400 in patients with chronic viral hepatitis or cirrhosis of any cause
* For CM patients: Diagnosis of colorectal cancer with metastasis to the liver confirmed by histology/cytology.
* Has ECOG performance status 0-1 before treatment intervention.
Inclusion Criteria Specific to Treatment Arm:
* Surgical Resection
* Has received no anti-cancer specific treatment for HCC i.e. previous liver resection, loco-regional therapy (e.g. RFA, TACE, SIRT), radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy within 4 weeks prior to the date of the planned surgery.
* Has adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria:
* Absolute neutrophil count ≥ 1.0 x 10\^9/L
* Platelet count ≥ 50 x 10\^9/L
* Haemoglobin ≥ 9.0 g/dL
* INR ≤ 2.0
* Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)
* Albumin ≥ 2.5 g/dL
* Total bilirubin ≤ 1.5 times the ULN
* Alanine transaminase (ALT) ≤ 2.5 times the ULN
* Aspartate Transaminase (AST) ≤ 2.5 times the ULN
* Has Child-Pugh score ≤ 7.
* Y90 treatment
* Y-90 therapy as the main treatment.
* Has Child-Pugh score ≤ 7.
* Systemic therapy
* Systemic therapy as the only treatment.
* Has Child-Pugh score ≤ 8
Exclusion criteria:
Common Exclusion Criteria (Surgical Resection, Y90 Treatment and Systemic Therapy):
* Has low creatinine clearance (estimated glomerular filtration rates \< 60)
* Is unable to return for follow-up visits to monitor for disease response/progression
* Is unable to have a MRI scan, including but not limited to claustrophobia, implanted metallic devices and metal foreign bodies
* Non-provision of informed consent
* For female patients: pregnant or lactating
Exclusion Criteria Specific to Treatment Arm:
* Surgical resection
* Has encephalopathy.
* Has received a major organ allograft.
* Has an uncontrolled bleeding disorder.
* Has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
* Has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
* Has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
* Y90 treatment
o Nil
* Systemic therapy
* Receiving concurrent therapy alongside systemic therapy.
* Has no anti-cancer specific treatment within 4 weeks prior to the initiation of systemic therapy.
* Has encephalopathy.
* Has history of allergic disease or reactions likely to be exacerbated by any component of treatment.
* Has had a solid organ or hematologic transplant. Has clinically apparent ascites on physical examination. Note: Ascites detectable on imaging studies only are allowed.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has current pneumonitis or known history of, or any evidence of active, non-infectious pneumonitis that requires steroids.
* Has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or any uncontrolled arrhythmia at the time of enrolment into study.
* Has known psychiatric or addictive disorders that may compromise the patient's ability to give informed consent, or to comply with trial procedures.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
* Has had a minor surgery ≤7 days prior to the first dose of systemic therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04451603
Study Brief:
Protocol Section:
NCT04451603