Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07718490
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab\[1200mg i.v, q3w\], Capecitabine \[1000mg/m² po, bid, d1-d14, q3w\], Oxaliplatin \[130mg/m² i.v, d1, q3w\], Bevacizumab \[7.5mg/kg i.v, d1, q3w\], Simvastatin \[80mg po qd\] regimen treatment, 6-8 weeks, then enter the maintenance phase, with oxaliplatin discontinued during the maintenance phase

Study Details

Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H/dMMR is present in only 15%-20% of stage II/III and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR/MSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.

Key Dates

First listed
Jul 22, 2026
Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Adebrelimab + Chemotherapy + Targeted Therapy + Simvastatin

Primary Outcome Measure

Investigator-assessed Objective Response Rate（ORR） [ Time Frame: 2 years. ]

Central Contacts

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