Trial Title:
The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer
NCT ID:
NCT05555901
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Conditions: Keywords:
Fruquintinib plus Chemotherapy
second-line treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
fruquintinib plus chemotherapy vs bevacizumab plus chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib+ chemotherapy
Description:
Second-line treatment : Fruquintinib+FOLFIRI Drug: Fruquintinib 4mg, orally, once daily,
3 weeks on/ 1 week off, q4w
Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus
5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on
day 1, q2w
Maintenance treatment：Fruquintinib+Capecitabine Drug: Fruquintinib 4mg, orally, once
daily, 2 weeks on/ 1 week off, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w
Arm group label:
Fruquintinib+ chemotherapy
Intervention type:
Drug
Intervention name:
Bevacizumab+ chemotherapy
Description:
Second-line treatment : Bevacizumab+FOLFIRI Drug: Bevacizumab 5mg/kg on day 1, q2w
Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus
5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on
day 1, q2w
Maintenance treatment：Bevacizumab+Capecitabine Drug: Bevacizumab 7.5mg/kg on day 1, q3w
Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w
Arm group label:
Bevacizumab+ chemotherapy
Summary:
This is a prospective, multi-center, randomized study evaluating the efficacy and safety
of fruquintinib combined with chemotherapy vs bevacizumab combined with chemotherapy as
second-line treatment in patients with metastatic colorectal cancer. Patients will
receive fruquintinib+ FOLFIRI or bevacizumab+FOLFIRI as the second-line treatment. After
receiving 4-6 months of second-line treatment, patients who achieve disease control will
receive fruquintinib + capecitabine or bevacizumab+ capecitabine as maintenance
treatment. All patients will be treated until progressive disease, death from any cause,
unacceptable toxicity or informed consent withdrawal.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged 18-75years (inclusive);
- Body weight ≥40 kg;
- Histological or cytological confirmed colorectal cancer;
- Expected survival >12 weeks;
- Fail in previous first-line standard therapy, which must include a fluorouracil
(5-fluorouracil or capecitabine), oxaliplatin ;
- At least one measurable lesion (according to RECIST1.1);
- Adequate hepatic, renal, heart, and hematologic functions;
- Negative serum pregnancy test at screening for women of childbearing potential.
Exclusion Criteria:
- Received radiation therapy, surgical procedure, chemotherapy, immunotherapy or
molecular targeted therapy, or other investigational drugs within 4 weeks prior to
treatment
- Prior treatment with anti-angiogenic small molecule targeted drugs, such as
fruquintinib, etc
- Prior treatment with an irinotecan-based chemotherapy regimen
- Symptomatic brain or meningeal metastases (except for patients with BMS who have
received local radiotherapy or surgery for more than 6 months and whose disease is
stable);
- Patients with hypertension that cannot be well controlled by antihypertensive
medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months
before treatment (bleeding > 30 mL within 3 months, hematemesis, black feces,
hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Treatment for
venous/venous thrombosis events within the previous 6 months, such as
cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage,
cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term
anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy
(aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
- Tumor invasion of large vascular structures, such as pulmonary artery, superior vena
cava or inferior vena cava, was found during screening, which was judged by the
investigator to have a greater risk of bleeding;
- Active heart disease, including myocardial infarction, severe/unstable angina, 6
months prior to treatment. Echocardiography examination left ventricular ejection
fraction < 50%, arrhythmia control is not good;
- The patient has had other malignant tumors within 5 years (except cured basal cell
carcinoma of the skin and carcinoma in situ of the cervix);
- Allergy to the study drug or any of its excipients;
- Severe infection with active or uncontrolled infection;
- Any other disease, with clinical significance of metabolic abnormalities, abnormal
physical examination or laboratory abnormalities, according to researchers, there is
reason to suspect the patient has not suitable for the use of study drugs of a
disease or condition (such as have a seizure and require treatment), or will affect
the interpretation of results, or to make patients in high-risk situations;
- Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital of Putian City
Address:
City:
Putian
Zip:
351100
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanchang Xu
Facility:
Name:
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guiying Wang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaobing Chen
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shan Zeng
Facility:
Name:
Qilu Hospital of Shandong University (QLH)
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong Dai
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266071
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wensheng Qiu
Facility:
Name:
Renji hospital, Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zizhen zhang, phd
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Zhang
Facility:
Name:
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Address:
City:
Shanghai
Zip:
201801
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ren Zhao
Facility:
Name:
the Second Affiliated Hospital of Medical College of Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Yuan, Ph.D & MD
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiquan Qin
Facility:
Name:
Sir Run Run Shaw Hospital
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhangfa Song
Facility:
Name:
Zhongshan hosptial, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianmin Xu, PhD
Phone:
+86-13501984869
Email:
xujmin@aiiyun.com
Start date:
June 18, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555901
