Status:
COMPLETED
Clinical Application of PD-1 Inhibitor in Colorectal Cancer for Improving Survival
Lead Sponsor:
Yanhong Deng
Conditions:
Rectal Cancer
Colon Cancer
Eligibility:
All Genders
Brief Summary
This trial is a single-center retrospective study. Eligible patients receiving PD-1 inhibitor treatment will enrolled.
Detailed Description
In patients with colorectal cancer (CRC), curative surgery combined with chemotherapy ( FOLFOX or CAPOX regimens) has become the standard treatment. However, 20 to 30% of these patients will develop d...
Eligibility Criteria
Inclusion
- :
- Willing and able to provide written informed consent. Histological or cytological documentation of adenocarcinoma of the colorectal. Eastern Cooperative Oncology Group's (ECOG) performance status of 0 or 1. CT or MRI scans (done within 30 days of registration) of the chest, abdomen, and pelvis all without clear evidence of distant metastatic (M1) disease.
- No clinically significant obstruction, perforation, or bleeding related to the primary tumor.
- No previous systemic anticancer therapy for colon cancer disease. Adequate bone marrow, hepatic, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment
Exclusion
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years before randomization.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
- Heart failure grade III/IV (NYHA classification). Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
- Subjects with known allergy to the study drugs or any of its excipients. Current or recent (within 4 weeks before starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Breast-feeding or pregnant women Lack of effective contraception.
Key Trial Info
Start Date :
March 20 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2025
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT06900686
Start Date
March 20 2013
End Date
March 23 2025
Last Update
March 28 2025
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