Clinical trial NCT05555901: The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer
Official title: The Efficacy and Safety of Fruquintinib Combined With Chemotherapy vs Bevacizumab Combined With Chemotherapy as Second-line Treatment in Patients With Metastatic Colorectal Cancer: A Prospective, Multi-center, Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Fruquintinib plus Chemotherapy
second-line treatment
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: fruquintinib plus chemotherapy vs bevacizumab plus chemotherapy
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
measure: Disease Control Rate (DCR)
timeFrame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
measure: Overall survival (OS)
timeFrame: from randomization until death due to any cause, assessed up to 2 year
Other outcomes:
Locations:
city: Putian
country: China
facility: The First Hospital of Putian City
state: Fujian
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Jinan
country: China
facility: Qilu Hospital of Shandong University (QLH)
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Renji hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
state: Shanghai
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Medical College of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Zhongshan hosptial, Fudan University
Study officials:
References: