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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01695772 |
Recruitment Status :
Completed
First Posted : September 28, 2012
Results First Posted : July 28, 2016
Last Update Posted : June 9, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: 5-FU based doublet chemotherapy Drug: bevacizumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Single-Arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer |
Actual Study Start Date : | October 16, 2012 |
Actual Primary Completion Date : | April 4, 2015 |
Actual Study Completion Date : | May 12, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Bevacizumab |
Drug: 5-FU based doublet chemotherapy
Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels. Drug: bevacizumab 5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively
Other Name: Avastin |
- Percentage of Participants Achieving Complete Resection (R0 Resection) [ Time Frame: At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks) ]R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.
- Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection) [ Time Frame: At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks) ]R1 resection was defined as achievement of incomplete tumor resection with microscopic involvement of a margin after pre-operative chemotherapy plus bevacizumab, as confirmed by pathology. Participants with R1 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.
- Percentage of Participants Achieving Objective Response [ Time Frame: Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall) ]Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
- Number of Participants With Disease Progression or Relapse or Death [ Time Frame: Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall) ]According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.
- Progression Free Survival (PFS) [ Time Frame: Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall) ]Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.
- Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18 [ Time Frame: Months 3, 6, 9, 12, 15, and 18 ]Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.
- Number of Participants With Disease Relapse or Death [ Time Frame: Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall) ]
- Disease Free Survival (DFS) [ Time Frame: Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years) ]Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.
- Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12 [ Time Frame: Months 3, 6, 9, and 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695772
China | |
Beijing Cancer Hospital | |
Beijing, China, 100142 | |
Sun Yet-sen University Cancer Center | |
Guangzhou, China, 510060 | |
The Second Affiliated Hospital of Zhejiang University College | |
Hangzhou, China, 310009 | |
The 2nd Affiliated Hospital of Harbin Medical University | |
Harbin, China, 150001 | |
Zhongshan Hospital Fudan University | |
Shanghai, China, 200032 | |
Liaoning cancer Hospital & Institute | |
Shenyang, China, 110042 | |
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | |
Wuhan, China, 430022 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01695772 |
Other Study ID Numbers: |
ML28419 |
First Posted: | September 28, 2012 Key Record Dates |
Results First Posted: | July 28, 2016 |
Last Update Posted: | June 9, 2017 |
Last Verified: | May 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |