Can a drug combo shrink liver tumors enough for surgery?
NCT ID NCT02350530
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding bevacizumab to a powerful four-drug chemotherapy regimen (FOLFOXIRI) could shrink liver tumors in people with colorectal cancer that had spread only to the liver and could not be removed surgically. The goal was to see if more patients could then have surgery to remove all visible cancer. The trial enrolled 138 adults and compared the combination therapy to chemotherapy alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOXIRI (a combination of four chemotherapy drugs: irinotecan, oxaliplatin, leucovorin, and 5-fluorouracil) with or without bevacizumab (a drug that blocks blood vessel growth to tumors)
- What this could lead to
- If successful, this approach could help more people with colorectal cancer that has spread to the liver become eligible for surgery, which may improve long-term survival.
- What could go wrong
- This is a phase 2 study with only 138 participants, so results may not apply to everyone. Adding bevacizumab to strong chemotherapy can increase side effects like low white blood cell counts and high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2015
- Finished
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Jan 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum. 3. Male or female subjects \> 18 years \< 70 of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. There must be documentation by CT scan, MRI, or intraoperative palpation that the patient has evidence of metastases confined to the liver. 6. The liver metastases must have been assessed by multidisciplinary team including hepatic surgeon approved to participate in the study to be unresectable based on at least one of the four criteria: 1. All of the liver metastases can not be completed resected with negative margins; 2. No ability to preservation of two contiguous hepatic segments; 3. No ability to preservation of adequate vascular inflow and outflow as well as biliary drainage; 4. Complete resection would require greater than 70% of the liver parenchyma to be removed. 7. The colorectal primary tumor or metastatic tumor must be determined to be KRAS (exon 2 at codon 12 and 13; exon 3 at codon 59 and 61; exon 4 at codon 117 and 146) or NRAS (exon 2 at codon 12 and 13; exon 3 at codon 59 and 61; exon 4 at codon 117 and 146) mutation-type. 8. Primary tumor and regional nodes were resected with clear surgical margins or; unresected primary tumor with plan to radical resect the primary tumor. 9. No previous any systemic anticancer therapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago). 10. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Hemoglobin (Hb) ≥ 90g/ L, absolute neutrophil count (ANC) ≥ 1.5×109/ L, platelet count ≥ 100×109/ L; Total bilirubin ≤ 1.5×the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 ×ULN; Serum creatinine ≤1.5×the ULN. Exclusion Criteria: 1. Any evidence of extrahepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence. 2. Previous hepatic resection and/or ablation, hepatic arterial infusion therapy, radiation therapy to the liver. 3. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization. 4. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. 5. Heart failure grade III/IV (NYHA-classification). 6. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure. 7. Subjects with known allergy to the study drugs or to any of its excipients. 8. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 9. Breast- feeding or pregnant women 10. Lack of effective contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
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Other studies related to the condition(s) this trial covers.
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