NCT05747716
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC
Not Yet Recruiting · Phase 2 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · registry updated 2023-02-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.
Inclusion
- Patients must have biopsy proven unresectable MCRC.
- Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
- Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
Exclusion
- Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (\>10%) in the prior 3 months.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- Patients with more than 5 discrete metastatic lesions.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.