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Clinical Trial Finder

Search Results

Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer

Study Purpose

This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have been fully informed about the study and have voluntarily signed an informed consent form; - Aged 18-75 years (inclusive of 18 and 75 years); - Pathologically determined unresectable advanced metastatic colorectal cancer; - Failure of prior second- and back-line standard therapy; - pMMR or MSS; - ECOG physical status score of 0-2; - Expected survival ≥ 6 months; - Need to have at least one measurable lesion with a maximum diameter of at least 10 mm as determined by spiral CT scanning and at least 20 mm as determined by conventional CT scanning (Criteria for Evaluation of Efficacy in Solid Tumors, i.e., RECIST version 1.1); - The function of vital organs meets the following requirements (the use of any blood components and cell growth factors is not permitted within *14d prior to enrollment): absolute neutrophil count ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥90g/L; total bilirubin <1.5 times ULN; ALT and/or AST <1.5 times ULN, and for patients with liver metastases <3 times ULN; serum creatinine <1.5 times ULN; endogenous creatinine clearance ≥50 ml/min; - Men and women of childbearing age need to use effective contraception; - Not allergic to inulin; - Subjects agree to provide sufficient blood and fecal samples for immune function and intestinal microbiology testing.

Exclusion Criteria:

  • - Inability to comply with the study protocol or study procedures; - Prior treatment with a vascular endothelial growth factor receptor (VEGFR) inhibitor or prior treatment with an immune checkpoint inhibitor; - Other malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; - The presence of central nervous system (CNS) metastases or previous brain metastases prior to enrollment.
  • - autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment.
  • - Previous allogeneic bone marrow transplantation or organ transplantation; - Uncontrolled malignant ascites (defined as ascites that, in the judgment of the investigator, cannot be controlled by means of diuretics or puncture); - Severe cardiovascular disease, including unstable angina or myocardial infarction, within 6 months prior to initiation of study treatment, clinically significant cardiovascular disease, including unstable angina or myocardial infarction, within 6 months prior to initiation of study treatment, including, but not limited to, acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive Heart failure New York Heart Association (NYHA) classification >2; Ventricular arrhythmia requiring pharmacologic treatment; LVEF (left ventricular ejection fraction) <50%; - Subjects with hypersensitivity to the study drug or any of its adjuvants; - Have participated in a clinical trial of another drug not yet approved or marketed in China within 4 weeks prior to enrollment and have been treated with the corresponding trial drug; - Electrolyte abnormalities of clinical significance as determined by the investigator; - Pre-existing medically uncontrolled hypertension, defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg; - The presence of poorly controlled diabetes mellitus (fasting glucose concentration ≥ CTCAE grade 2 after regular treatment) prior to enrollment; - Any disease or condition that interferes with drug absorption prior to enrollment or the patient is unable to take Fruquintinib orally; - The presence of gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors prior to enrollment, or other conditions that may cause gastrointestinal bleeding or perforation, as determined by the investigator; - Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, vomiting blood, black stool, blood in stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke events and/or transient ischemic attack) within 12 months; - Active or uncontrolled serious infection (≥ CTCAE v5.0 grade 2 infection); - Known human immunodeficiency virus (HIV) infection.
Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., HBV DNA-positive (>1×10^4 copies/mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and HCV RNA-positive (>1×10^3 copies/mL)];
  • - Unresolved toxic reactions above CTCAE v5.0 Grade 1 or higher due to any prior anticancer therapy, excluding alopecia, lymphopenia, and neurotoxicity ≤ Grade 2 due to oxaliplatin; - Females who are pregnant (positive pregnancy test prior to dosing) or breastfeeding; - Transfusion therapy, blood products, and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), received within 14 days prior to enrollment; - Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities that, in the judgment of the investigator, give reason to suspect that the patient has a disease or condition for which the use of the study medication is inappropriate (e.g., has epileptic seizures that require treatment), or that would interfere with the interpretation of the study results, or that would place the patient at a high level of risk.
  • - Those with routine urinalysis suggestive of urinary protein ≥2+ and a 24-hour urine protein volume >1.0 g; - Complications requiring long-term immunosuppressive therapy or requiring systemic or topical immunosuppressive corticosteroids (>10 mg/day prednisone or other therapeutic hormones); - Use of antibiotics or probiotic preparations (probiotic candies, powders, pills, probiotic juices, probiotic yogurts, oligosaccharides, etc.) within the last month.
  • - Patients who, in the opinion of the investigator, are not suitable for enrollment in this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06347198
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wuhan Union Hospital, China
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Colorectal Cancer
Additional Details

This was a prospective, two-arm, single-center, exploratory phase I study, randomized 2: 1 into an intervention group (Fruquintinib combined with Sintilimab and inulin group) and a control group (Fruquintinib combined with Sintilimab group). Fruquintinib: 4 mg/d, QD po, administered continuously for 2 weeks with a 1-week discontinuation; Sintilimab 200 mg, I.V., D1, administered every 3 weeks; Inulin: 5 g/d, qd po, in the first week, and 10 g/d, bid po, starting in the second week; Combination therapy was administered every 3 weeks as a treatment cycle. Combination therapy was administered until disease progression, death, or intolerable toxicity. The study was divided into 3 phases: a screening phase, a treatment phase, and a follow-up phase. Tumor status was assessed using imaging methods every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included changes in AE, laboratory test values, vital signs, and electrocardiographic changes.

Arms & Interventions

Arms

Experimental: Intervention group (Fruquintinib combined with Sintilimab and inulin group)

Other: Control group (Fruquintinib combined with Sintilimab group)

Interventions

Drug: - Fruquintinib

Fruquintinib: 4 mg/d, qd po, administered continuously for 2 weeks, discontinued for 1 week;

Drug: - Sintilimab

Sintilimab: 200 mg, i.v.gtt.D1, administered every 3 weeks;

Drug: - Inulin

Inulin: 5g/d, qd po in the first week, 10g/d, bid po from the second week onwards.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Min Jin, Wuhan, Hubei, China

Status

Recruiting

Address

Min Jin

Wuhan, Hubei, 430030

Site Contact

Min Jin

[email protected]

18807108606

Nearest Location

Site Contact

Min Jin

[email protected]

18807108606


Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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