Actively Recruiting
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-05-13
30
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
FOLFOXIRI-based regimen is more used as a first-line therapeutic approach for patients diagnosed with unresectable or metastatic colorectal cancer for its superior efficacy. However, there are no standard recommendations for second-line therapy after progression on FOLFOXIRI with or without targeted therapy. Here, the investigators conduct this open-label, single arm phase II study to evaluate whether fruquintinib in combination with camrelizumab and capecitabine can be the salvage therapy following FOLFOXIRI based regimen for mCRC. Patients diagnosed with unresectable or metastatic colorectal cancer progression on FOLFOXIRI-based regimen are included;or patients have progression or untolerated toxicity with irinotecan, oxaliplatin and fluorouracil successively within one year; patients with BRAF mutation were allowed to receive BRAF inhibitor therapy with or without MEK inhibitor therapy after FOLFOXIRI-based regimen. Patients participated in this study will receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, repeated every three weeks. The primary endpoint is Objective Response Rate(ORR). The investigators estimated that 30 patients were necessary. Secondary endpoints include progression-free survival, overall survival, safety, and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer.
CONDITIONS
Official Title
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or locally advanced unresectable colorectal cancer confirmed by histology or cytology
- Metastases after radical resection of colorectal cancer without need for additional confirmation if within 5 years of surgery
- Progression or intolerance to first-line FOLFOXIRI-based treatment with or without targeted drugs within one year
- Patients with BRAF mutations treated with BRAF inhibitor alone or with MEK inhibitor after FOLFOXIRI-based regimen
- Target lesion defined by RECIST criteria
- Age 18 years or older with ECOG performance status of 0 to 2
- Estimated life expectancy of at least 12 weeks
- Adequate blood, liver, and kidney function per specified laboratory criteria
- International normalized ratio or activated partial thromboplastin time less than 1.5 times upper limit of normal
- Negative pregnancy test within 7 days before enrollment or non-reproductive potential; agreement to use contraception during study
- Consent to provide blood samples for relevant analyses
- Ability to understand and sign informed consent
You will not qualify if you...
- Antitumor chemotherapy or biotherapy within 28 days before first investigational drug dose, except a single radiotherapy dose up to 8 Gy for pain relief
- Untreated or symptomatic brain metastases
- History of significant heart disease including congestive heart failure grade II or higher, recent myocardial infarction, unstable angina, or arrhythmias requiring therapy unless stable
- Uncontrolled hypertension or history of hypertensive crisis
- History of arterial thrombosis or embolism within 6 months
- Critical vascular diseases such as aortic aneurysm or dissection
- Bleeding tendency or coagulation disorders
- Major surgery within 14 days or minor surgery within 7 days prior to enrollment
- Abdominal fistula, gastrointestinal perforation, peptic ulcer, or abdominal abscess in past 6 months
- Severe, non-healing wounds, ulcers, or fractures
- History of posterior reversible encephalopathy syndrome
- Prior treatment with fruquintinib
- Inability to swallow tablets or malabsorption syndrome
- Active autoimmune disease or history of autoimmune disease with possible recurrence; asthma requiring medical intervention excluded
- Immunosuppressive or systemic hormone therapy over 10 mg prednisone daily within 14 days prior to study
- Severe infection within 4 weeks prior to treatment initiation
- Congenital or acquired immune deficiency such as HIV infection
- Receipt of live attenuated vaccines within 28 days prior to treatment or planned during camrelizumab therapy
- Other factors affecting study results or safety as judged by investigator, including alcoholism, drug abuse, serious diseases, mental illness, or social factors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qiong Yang, Doctor
CONTACT
K
kaicong zhang, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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