Can delivering cancer drug directly to the liver shrink tumors?
NCT ID NCT01677884
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase II trial is investigating whether giving the drug bevacizumab directly into the liver's main artery, alongside standard chemotherapy, can shrink liver tumors in people with colorectal cancer that has spread only to the liver. The study enrolls patients whose cancer progressed after first-line chemotherapy and who are not candidates for curative surgery. The main goal is to measure the tumor response rate, with secondary goals of assessing side effects, progression-free survival, and whether the treatment might enable later surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bevacizumab given directly into the liver artery, combined with standard chemotherapy (capecitabine plus either irinotecan or oxaliplatin).
- What this could lead to
- If effective, this approach could offer a new treatment option for people with colorectal cancer that has spread to the liver and is no longer responding to first-line chemotherapy.
- What could go wrong
- This is a small, early-phase study, so results may not apply broadly. The treatment may cause side effects, and the response rate could be lower than hoped.
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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10 people
The number who actually took part.
- Start date
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Nov 2012
- Finished
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Feb 2016
- 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 75 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: * Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases) * Isolated (no extra-hepatic metastasis, primary tumor resected) * No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP) * which at least one measurable by RECIST (\>2 cm, or \>1 cm if Computed tomography (CT) spiraled) * Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection) * colon or rectal primary tumor : resected or asymptomatic * Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab * Age \>18 years \<75 years * Performance status WHO 0 or 1 * Life expectancy \>3 months * Bilirubin \<1.5 times the upper limit of normal (N), ASAT and ALAT \<5N, creatinine \<1.5 N neutrophils \>1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin \>9g/dL. Patients may be included even if they were transfused * CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle * Information of the patient or legal representative signing the informed consent * Affiliated to a social security system Exclusion Criteria: * Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome) * Extra-hepatic metastases other than small size disease potentially accessible after resection * Grade 3-4 allergy to one of the treatment compounds * Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment. * Participation during or within 30 days before study to another therapeutic trial with an experimental molecule * Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone * Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment * Uncontrolled hypertension (blood pressure \>150/100 mm Hg despite hypertensive treatment) * Heart Failure \>Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure * History and / or presence of bleeding disorders and/or thrombotic \<6 months * Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment * Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age * Occlusion or sub-bowel obstruction or history of inflammatory bowel disease * Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated) * Legal inability (persons deprived of liberty or under guardianship) * Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.
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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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Institut Gustave Roussy
Villejuif, Val de Marne, 94805, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
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- AI reads tumor slides to match cancer patients with trials
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