Clinical trial · Interventional
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy
NCT01677884CI-TRIAL-00121966BEVIACcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with metastatic CRC
- interventionNames
- Drug: Bevacizumab
- Drug: Capecitabine
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Efficiency of treatment based on objective response rate
- timeFrame
- Every 9 weeks from the start to tumoral progression
Secondary outcomes (3)
- measure
- Treatment toxicity based on NCI-CTC v4.0
- timeFrame
- Every 3 weeks from the start to tumoral progression or toxicity preventing further processing
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRigault E, Lacas B, Glehen O, Smith D, Dupont-Bierre E, Guimbaud R, Malka D, Boige V, Fuerea A, Pignon JP, Ducreux M. Intra-arterial hepatic bevacizumab and systemic chemotherapy in hepatic metastasis of colorectal cancer: A phase II multicentric trial in second-line treatment. Cancer Treat Res Commun. 2023;34:100674. doi: 10.1016/j.ctarc.2022.100674. Epub 2022 Dec 16. PMID 36565566