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Completed

NCT Number: NCT06900686

Clinical Application of PD-1 Inhibitor in Colorectal Cancer for Improving Survival

This trial is a single-center retrospective study. Eligible patients receiving PD-1 inhibitor treatment will enrolled.

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Key information

About this study

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 distant metastasis, which ultimately results in death. Oxaliplatin- and fluoropyrimidine-based doublet chemotherapy does not adequately meet the clinical need for tumor shrinkage and downstaging. There is an urgent need to explore drugs with different mechanisms of action in combination with chemotherapy to improve efficacy. Relatively few trials of preoperative therapy have been reported, In recent years, the emergence of immune checkpoint inhibitors has revolutionized cancer treatment. Given the limitations of current treatment strategies in achieving optimal clinical outcomes, this retrospective study aims to research the disease-free survival rates and overall survival (OS) in CRC patients using PD-1 inhibitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Inclusion criteria

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 criteria

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.

Treatment and study plan

PD1 Inhibitor

Drug

PD1 Inhibitor

Primary outcomes

  1. DFS

    Time frame: 3years

    disease-free survival

Sponsors and collaborators

Lead sponsor

Yanhong Deng

Other

Registry information

Official study title

A Retrospective Study of the Effect of PD-1 Inhibitors in Improving Clinical Outcome for Colorectal Cancer.

Important dates

Study start
2013
Primary completion
2022
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.