Health TrialsbyHealthPanel

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

ConditionsColorectal CancerMicrosatellite Stable Colorectal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old, both sexes;

Patients with histologically or cytologically confirmed unresectable and metastatic CRC;

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).

Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;

Disqualifiers

Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor;

Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS

Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody;

Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;

Trial design

Design model

Single group

Treatments tested in this trial

  • Vitamin E

    Drug

    Vitamin E: 400mg (QD), oral, once daily, continued until disease progression or intolerable toxicity.

  • Fruquintinib

    Drug

    Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.

  • Tislelizumab

    Drug

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Vitamin E in combination with Fuquinitinib and TislelizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

objective response rate (ORR)

The proportion of participants whose best outcome is complete remission or partial remission

Time frame
2 year

Secondary outcomes

1

progression-free survival (PFS)

Time from initiation of treatment to disease progression or death from any cause.

Time frame
2 year
2

overall survival (OS)

The time between the start of the participants' treatment and their death from any cause

Time frame
2 year
3

disease control rate (DCRs)

The proportion of patients without disease progression (PD).

Time frame
2 year
4

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).

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
Apply now