Phase 4
Completed N=50
A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer
Source: ClinicalTrials.gov NCT01695772 ↗Enrolled (actual)
50
Serious AEs
8.0%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Achieving Complete Resection (R0 Resection) — 30.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Resection (R0 Resection) |
30.0 | — |
| SECONDARY Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection) |
0.0 | — |
| SECONDARY Percentage of Participants Achieving Objective Response |
30.0 | — |
| SECONDARY Number of Participants With Disease Progression or Relapse or Death |
28 | — |
| SECONDARY Progression Free Survival (PFS) |
12.06 | — |
| SECONDARY Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18 |
97.7; 76.4; 59.5; 51.5; 30.0; 21.4 | — |
| SECONDARY Number of Participants With Disease Relapse or Death |
20 | — |
| SECONDARY Disease Free Survival (DFS) |
8.48 | — |
| SECONDARY Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12 |
80.0; 70.0; 40.0; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult Chinese participants, 18-75 years of age
- Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed
- Previously untreated unresectable liver-only metastases
- Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).
- No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy
- Adequate hematological, renal and hepatic function
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than (>) 3 months
Exclusion Criteria
- The relapse has occurred within 6 months of completion of the adjuvant treatment
- Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy
- Participant cannot tolerate the surgery
- Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- Any extrahepatic metastases and/or recurrence of the primary tumor
- Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2
- Hypertension crisis or encephalopathy
- Pregnant or lactating women
- Clinically significant cardiovascular disease
- Evidence of bleeding diathesis or coagulopathy
- Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin
- History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
Data sourced from ClinicalTrials.gov (NCT01695772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.