Actively Recruiting
Fruquintinib Combined With Adebrelimab and Radiotherapy for Second-Line and Beyond MSS Metastatic Colorectal Cancer Treatment
Led by Ningbo Medical Center Lihuili Hospital · Updated on 2024-09-25
30
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
N
Ningbo Medical Center Lihuili Hospital
Lead Sponsor
S
Shanghai Shengdi Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the combination of Fruquintinib, Adebrelimab, and both high and low dose radiotherapy in treating adults with microsatellite stable (MSS) metastatic colorectal cancer who have not responded to second-line or further treatments. The main focus is to assess the effectiveness and safety of this combination as a third-line or later therapy option. Participants will first receive targeted radiotherapy on metastatic sites using both high and low doses. Within three weeks after completing radiotherapy, they will begin treatment with Fruquintinib combined with Adebrelimab. This combined treatment will continue until the cancer progresses or intolerable side effects occur. During the study, tumor response will be evaluated every six weeks using imaging based on RECIST 1.1 criteria. Researchers will monitor overall response rate over one year and secondary outcomes including progression-free survival, overall survival, disease control rate, duration of response, and adverse events for up to three years. Participants will be closely observed for treatment effects and safety throughout the study period.
CONDITIONS
Brief Title
Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- Diagnosed with microsatellite stable metastatic colorectal cancer
- Disease progression after standard second-line treatment per Chinese Society of Clinical Oncology guidelines
- At least one measurable lesion according to RECIST 1.1
- Ability to follow the study protocol during the research period
- Signed informed consent form
You will not qualify if you...
- History of uncontrolled epilepsy, central nervous system disorders, or mental disorders affecting consent or medication adherence
- Presence of other untreated malignant tumors
- Blood and biochemical test results outside specified safety ranges
- Serious active heart disease or recent myocardial infarction within 12 months
- Irreversible clotting problems or active major bleeding
- Active infections requiring antibiotics
- Allergy to any study drug ingredients
- Pregnant or breastfeeding women
- History of organ transplantation requiring immunosuppressive or long-term hormone therapy
- Autoimmune diseases
- Prior drug treatments in earlier plans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants receive high and low dose radiotherapy on metastases before starting drug treatment.
Visits as needed during radiotherapy
Duration - Until disease progression or intolerable toxicity
Participants receive the combination of Fruquintinib and Adebrelimab until disease progression or intolerable toxicity occurs.
Clinical tumor imaging evaluation every 6 weeks (±7 days)
Trial Site Locations
Total: 1 location
1
Kaitai Liu
Ningbo, Zhejiang, China, 315040
Actively Recruiting
Research Team
K
Kaitai Liu, doctor
S
Shuang Ye, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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