Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)
1 other identifier
interventional
30
1 country
1
Brief Summary
This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Oct 2018
Typical duration for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2018
CompletedFirst Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 19, 2021
August 1, 2021
3.2 years
October 31, 2018
August 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate(ORR)
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.
up to 55 months
Secondary Outcomes (4)
Disease Control Rate (DCR)
up to 55 months
Progression-free survival
Time from treatment beginning until the date of first documented progression, assessed up to 55 months
Overall survival
Time from treatment beginning until date of death from any cause, assessed up to 55 months
adverse events
Through study completion, an average of 4 weeks
Study Arms (1)
FIVC group
EXPERIMENTALIrinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course)
Interventions
Eligibility Criteria
You may qualify if:
- Patients have histologically or cytologically confirmed advanced or recurrent CRC;
- Patients with BRAV V600E mutation/KRAS WT based on the NGS or ARMS-PCR detection of tumor tissue;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
- Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
- Patients without a history of receiving vemurafenib or cetuximab;
- Patients with age of 18-75yr;
- Patients with a performance status of 0,1or 2 on the Eastern Cooperative Oncology Group.；
- Patients with Life expectancy of more than 12 weeks;
- Patients must have the ability to understand and sign the written informed consent voluntarily;
- Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
You may not qualify if:
- Patients with KRAS/NRAS mutation;
- Patients with major surgery or severe trauma within 4 weeks before the first medication;
- Patients with hypersensitivity to the components in the study protocol;；
- Patients who are ready to give birth or are pregnant.。
- Patients with brain metastases 。
- Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows：
- Neutrophil count\<1,500/mm3；
- Platelet count \<80,000/mm3；
- Total bilirubin \>1.5-times the upper limit of normal；
- ALT/AST\>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients without liver metastases)
- Creatinine \>1.5-times the upper limit of normal；
- Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;；
- Patients without legal capacity or limited civil capacity;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (1)
Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Dai WP, Sun L, Liu K, Qin WX, Jiao XD, Li XN, Zang YS. Cetuximab and vemurafenib plus FOLFIRI (5-fluorouracil/leucovorin/irinotecan) for BRAF V600E-mutated advanced colorectal cancer (IMPROVEMENT): An open-label, single-arm, phase II trial. Eur J Cancer. 2022 Mar;163:152-162. doi: 10.1016/j.ejca.2021.12.028. Epub 2022 Jan 21.
PMID: 35074651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhan Wang, Prof
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A single center clinical study of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 1, 2018
Study Start
October 8, 2018
Primary Completion
December 1, 2021
Study Completion
December 31, 2022
Last Updated
August 19, 2021
Record last verified: 2021-08