- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635149
Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Colorectal Cancer
Predictive Factors for Outcomes of Fruquintinib Plus Immunotherapy in Metastatic Colorectal Cancer:An Observational Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Min Jin, PhD
- Phone Number: 18807108606
- Email: minjin86@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Min Jin
-
Contact:
- Min Jin
- Phone Number: 18807108606
- Email: minjin86@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed the Informed Consent Form
- Ages: 18-75 Years (concluding 18 and 75 Years)
- Pathologically confirmed unresectable metastatic colorectal cancer
- Failure to 2st line therapy
- pMMR/MSS type
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy greater than 3 months
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan, larger than 20 mm in diameter by conventional CT scan) according to RECIST1.1
- Sufficient organ functions as follows (any blood transfusion or cell growth factor use within 14 days before enrollment is not allowed):
Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet Count of ≥175×109/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL) ≤1.5 x ULN; ALT and /or AST<1.5 x ULN; If there is liver metastasis, then ALT and/or AST<3.0 x ULN; Serum Creatinine (SCr) ≤1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min;
- Man and woman who childbearing potential agrees to use adequate contraception
- Willingness to provide enough tumor tissues for PD-L1 expression test
Exclusion Criteria:
- Patients could not obey the study protocol.
- Previous therapy with VEGFR Inhibitor or anti-PD-1 antibody.
- Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
- Known brain or CNS metastases.
- Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Uncontrolled malignant ascites.
- Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Participation in another clinical trial with any experimental drug within 4 weeks prior to enrollment.
- Clinically significant electrolyte abnormalities judged by researchers.
- Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs.
- Poorly controlled diabetes before enrollment.
- Any factors that influence the usage of oral administration and patients cannot take fruquintinib orally.
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator.
- Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months.
- Active infection or serious infection that is uncontrolled by drug (NCI CTCAE v. 5.0 Grade ≥ 2).
- History of clinically significant hepatic disease, including hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml or >2000IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/ml).
- Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1).
- Pregnant or breastfeeding female patient.
- Receive blood transfusion, blood products and hematopoietic factors such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days prior to enrollment.
- Other severe acute or chronic medical conditions including metabolic disorder, physical examination or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
- Use of immunosuppressive medication, or systemic/local immunosuppressive corticosteroids for complication.
- Patients considered unsuitable for inclusion in this study by the investigator.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fruquintinib and anti-PD-1 plus radiotherapy
Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. Patients with isolated or localized metastasis will receive radiotherapy. |
In radiotherapy group, the modality of radiotherapy was conventional radiotherapy (CRT) or stereotactic body radiotherapy (SBRT) for cancer.
Other Names:
|
Fruquintinib and anti-PD-1 alone
Fruquintinib is administrated as 4mg orally, once daily for 2 weeks on/1 week off. anti-PD-1 antibody is administrated as 200mg once every 3 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
|
PFS is defined as the time from randomization to the first documented disease
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
|
ORR is defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
|
from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
|
Adverse Event (AEs)
Time Frame: from the date of first dose to the 30 days post the last dose
|
Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
|
from the date of first dose to the 30 days post the last dose
|
Gut microbiome analysis
Time Frame: 16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients
|
To explore the association of gut microbiome and the efficacy of the treatment
|
16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory endpoint
Time Frame: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
|
To identify the correlation between PD-L1 expression and inflammatory factor score with clinical outcomes
|
from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenocarcinoma
Other Study ID Numbers
- UNION00168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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