Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have confirmed unresectable liver confined metastatic colorectal cancer
(CRC).
- Patient must not have radiographically or clinically evident extrahepatic disease
(including but not limited to radiographically positive periportal lymph nodes).
- NOTE: Patients found to have positive periportal nodes at the time of HAI
placement can remain on study.
- Patient may have calcified pulmonary nodules, and/or =< 5 indeterminate and
stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each
measuring =< 6 mm in maximal axial dimension.
- Patient's primary tumor may be in place.
- Patient must have received 3-6 months of previous first-line chemotherapy that meet
one of the following three criteria: a) have received at least 6 but no more than 12
cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have
received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy
(where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM)
within 12 months of completing adjuvant systemic therapy for stage II-III colorectal
cancer.
- NOTE: First-line chemotherapy may have included any of the following regimens as
listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin
calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent),
leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI)
(or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil,
oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the
following: bevacizumab, cetuximab, or panitumumab.
- Patient must have stable or responding disease on first-line chemotherapy by RECIST
1.1 criteria
- Patient must meet the following criteria for technical unresectability:
- A margin-negative resection requires resection of three hepatic veins, both
portal veins, or the retrohepatic vena cava OR a resection that leaves less than
two adequately perfused and drained segments.
- NOTE: Institutional multidisciplinary review is required to confirm
unresectability and rule out radiographically positive extrahepatic disease.
- Patient must undergo CT angiography (chest/abdomen/pelvis) to confirm acceptable
hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks
prior to randomization.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
and be clinically fit to undergo surgery as determined by the pre-operative
evaluation.
- Leukocytes >= 3,000/mcL (obtained =< 14 days prior to protocol randomization)
- Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 14 days prior to protocol
randomization)
- Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
- Total Bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to protocol randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
3.0 x institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol
randomization)
- Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min calculated
by the Cockcroft-Gault method (obtained =< 14 days prior to protocol randomization)
- Calcium >= institutional lower limit of normal (LLN)
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible for
this trial. Testing for HIV is not required for entry onto the study
Exclusion Criteria:
- Patient must not have a liver tumor burden exceeding 70% of total liver volume.
- Patient must not have had prior radiation to the liver (prior radiation therapy to the
pelvis is acceptable if completed at least 2 weeks prior to randomization).
- Patient must not have had prior trans-arterial bland embolization, chemoembolization
(TACE) or radioembolization (TARE).
- Patient must not have had prior treatment with HAI/floxuridine (FUDR)
- Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
- Patient must not have CRLM that could be resected with 2-stage hepatectomy, including
associating liver partition and portal vein ligation (ALPPS).
- Patient must not have an active infection, serious or non-healing active wound, ulcer,
or bone fracture.
- Patient must not have any serious medical problems which would preclude receiving the
protocol treatment or would interfere with the cooperation with the requirements of
this trial.
- Patient must not have cirrhosis and/or clinical or radiographic evidence of portal
hypertension
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn
fetus and possible risk for adverse events in nursing infants with the treatment
regimens being used.
- All patients of childbearing potential must have a blood test or urine study
within 14 days prior to randomization to rule out pregnancy.
- A patient of childbearing potential is defined as anyone, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not undergone
a hysterectomy or bilateral oophorectomy; or 3) has not been naturally
postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months).
- Patient must not expect to conceive or father children by using accepted and effective
method(s) of contraception or by abstaining from sexual intercourse for the duration
of their participation in the study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/22/23. Questions regarding updates should be directed to the study team contact.