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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05771181
Other study ID # VENTIF
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 2023
Est. completion date February 2027

Study information

Verified date March 2023
Source Fudan University
Contact Dawei Li, PhD
Phone +8613774201693
Email li_dawei@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.


Description:

Dietary supplements are commonly used during conventional cancer treatment. Vitamin E has a variety of functions, including enhancing immunity, anti-inflammation, and anti-oxidation. Tislelizumab is an anti-PD-1 monoclonal antibody, and furoquininib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with furoquininib has initial efficacy in the treatment of colorectal cancer. Whether vitamin E combined with immunotherapy and furoquininib can improve the prognosis of patients with colorectal cancer deserves to be studied. Therefore, the objective of this study is to evaluate the efficacy and safety of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date February 2027
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years old, both sexes; 2. Patients with histologically or cytologically confirmed unresectable and metastatic CRC; 3. Recist1.1-defined disease progression or intolerance to prior standard therapy during or after standard therapy. Standard therapy was required to include all the following agents: fluorouracilines, chemotherapy agents such as irinotecan, and oxaliplatin, with or without an anti-VEGF monoclonal antibody (e.g., bevacizumab). Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab). 4. Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS; 5. Patients with ECOG score of 0-1 and expected survival time =3 months, patients who can cooperate to observe adverse reactions and efficacy; 6. At least one measurable tumor lesion according to RECIST 1.1 criteria; 7. Good organ function: 1. neutrophil =1.5*109/L; Platelet =100*109/L; Hemoglobin =9g/dl; Serum albumin =3g/dl; 2. Thyroid stimulating hormone (TSH) = 1 times the upper limit of normal, T3 and T4 in the normal range; 3. bilirubin = 1.5 times the upper limit of normal value; ALT and AST= 2 times the upper limit of normal; 4. Serum creatinine = 1.5 times the upper limit of normal, creatinine clearance =60ml/min; 5. International normalized ratio (INR) or prothrombin time (PT) = 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy; 6. Activated partial thromboplastin time (aPTT) = 1.5 times the upper limit of normal; 8. There were no serious concomitant diseases that could make the survival time less than 5 years; 9. Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients; 10. Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol; 11. Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study; 12. Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures; 13. Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices. Exclusion Criteria: 1. Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor; 2. Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS 3. Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody; 4. Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 5. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma/allergy without any intervention in adulthood; 6. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation; 7. Contraindications to antiangiogenic drugs (such as active bleeding, gastrointestinal bleeding, hemoptysis, etc.); 8. History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia; 9. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment; 10. The subject has active hepatitis B (HBV DNA =2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay) 11. Severe cardiopulmonary and renal dysfunction; 12. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 13. A history of psychotropic substance abuse, alcohol or drug abuse; 14. Other factors that may affect subject safety or trial compliance as judged by the investigator. Severe medical conditions requiring concomitant treatment (including mental illness), serious laboratory abnormalities, or other family or social factors.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vitamin E
Vitamin E: 400mg (QD), oral, once daily, continued until disease progression or intolerable toxicity.
Fruquintinib
Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.
Tislelizumab
Tislelizumab: 200mg intravenously every 3 weeks (Q3W), was administered until the occurrence of unacceptable toxic effects, or disease progression, withdrawal of consent, or withdrawal as judged by the investigator.

Locations

Country Name City State
China 270 Dongan Road, Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary objective response rate (ORR) The proportion of participants whose best outcome is complete remission or partial remission 2 year
Secondary progression-free survival (PFS) Time from initiation of treatment to disease progression or death from any cause. 2 year
Secondary overall survival (OS) The time between the start of the participants' treatment and their death from any cause 2 year
Secondary disease control rate (DCRs) The proportion of patients without disease progression (PD). 2 year
Secondary advert events Assessment of the safety profile of regimen according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0). 2 year
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