Combining fruquintinib with chemotherapy for metastatic colorectal cancer treatment

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

This study is testing whether combining a new drug called fruquintinib with chemotherapy works better than using bevacizumab with chemotherapy for people with metastatic colorectal cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: fruquintinib, chemotherapy, immunotherapy, radiation, bevacizumab
• Locations: 13 sites (Putian, Fujian and 12 other locations)
• Trial ID: NCT05555901 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of fruquintinib in combination with chemotherapy compared to bevacizumab with chemotherapy as a second-line treatment for patients with metastatic colorectal cancer. Participants will receive either fruquintinib plus FOLFIRI or bevacizumab plus FOLFIRI for 4-6 months, followed by maintenance treatment with either fruquintinib plus capecitabine or bevacizumab plus capecitabine if they achieve disease control. The study aims to determine which combination is more effective in managing the disease and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed metastatic colorectal cancer who have failed previous first-line treatments.

Not a fit: Patients with symptomatic brain metastases or those who have previously received anti-angiogenic small molecule targeted drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic colorectal cancer who have not responded to first-line therapies.

How similar studies have performed: Previous studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating metastatic colorectal cancer.

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.

Where this trial is running

Putian, Fujian and 12 other locations

• The First Hospital of Putian City — Putian, Fujian, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University (QLH) — Jinan, Shandong, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Renji hospital, Shanghai Jiaotong University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Changhai Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School — Shanghai, Shanghai, China (Not_yet_recruiting)
• the Second Affiliated Hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhongshan hosptial, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jianmin Xu, MD

Conditions Metastatic Colorectal Cancer; Fruquintinib plus Chemotherapy; second-line treatment