Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorec… (NCT04695470) | Clinical Trial Compass
UnknownPhase 2
Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients
China70 participantsStarted 2020-09-01
Plain-language summary
This is a prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.
Patients had to have received at least a second-line standard therapy, including fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial growth factor) inhibitors and to have disease progression within 3 months after the last administration of the last standard therapy or to have stopped such therapy due to unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were mandatory if RAS(Rat sarcoma virus) wild and left side .
Patients who met the eligibility criteria took fruquintinib plus Sintilimab until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival) rate at 6 months.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fully understand the study and signed the Informed Consent Form (ICF) out of their own will;
. Histologically or cytologically diagnosed with metastasis colorectal adenocarcinoma CRC (Phase IV)
. MSS or MSI-low, MSI was assessed per local guidelines (immunohistochemistry and/or polymerase chain reaction \[PCR\]) prior to screening. Tumor samples with instability in 0 or 1 marker were identified as microsatellite-stable and MSI-low, respectively.
. TMB≥5 mutations/Mb, TMB was performed on plasma samples by NGS.
. Subjects who failed at least second line standard chemotherapies including Fluorouracil, Oxaliplatin, Irinotecan and VEGF inhibitors(e.g., bevacizumab). Pre-treatment with anti-EGFR(e.g., cetuximab) were mandatory if RAS wild and left side. Failed therapies are defined as the occurance of PD or intolerable toxicities during the treatment or within 3 months after the last dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject must not receive any systematically anti-tumor therapies during the last 4 weeks, and never receive any vascular endothelial growth factor (VEGFR) inhibitor or Immune checkpoint blockade.
. 18-75 years of age (inclusive)
. Body weight≥40Kg
Exclusion criteria
. with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
. Previous treatment with Fruquintinib or immune checkpoint inhibitors
. Absolute neutrophil count (ANC)\<1.5×109/L, or blood platelet count (PLT)\<100×109/L, or hemoglobin\<90g/L; blood transfusion within 1 week before enrollment for the purpose of enrollment is not allowed;
. Serum total bilirubin\>1.5×Upper Limit of Normal (ULN);Alanine transaminase(ALT) and/or Aspartate transferase (AST)\>2.5×ULN (subject to the normal value at each site); or ALT and/or AST \> 5×ULN for patients with liver metastases;
. Creatinineclearancerate\< 50mL/min;
. Uncontrolled hypertension by monotherapy, i.e. systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after monotherapy treatment.
. Clinical significant electrolyte abnormality;
. Results of urine protein detection with 2+ or above, or urinary protein quantity ≥1.0g/24h;