Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients

Sponsor
Fudan University
Study ID
NCT06999252
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Take 75 mg every other day
  • PD-1 — DRUG
    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.

Study Details

The goal of this clinical trial is to learn about efficacy of Rimegepant in combination with PD-1 in patients with liver metastasis colorectal cancer. 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.

Key Dates

Start date
Jul 1, 2025
Status verified
May 2025
Primary completion
Dec 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients will be treated with Rimegepant and PD-1

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: 2 year ]

Central Contacts

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