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

NCT06900686 | Completed

• 1 other identifier: GIHSYSU-RS-01
• Study Type: observational
• Target: 458
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rectal Cancer; Colon Cancer

Keywords

pd1

Outcome Measures

Primary Outcomes (1)

• DFS

  disease-free survival

  3years

Interventions

PD1 Inhibitor DRUG

PD1 Inhibitor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CRC patients receiving PD-1 inhibitors

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanhong Deng: lead

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: March 20, 2013
• Primary Completion: September 20, 2022
• Study Completion: March 23, 2025
• Last Updated: March 28, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share