Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-10-31

Brief Summary

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The purpose of this clinical research is to establish a multi-omics model based on genomics，transcriptomics，gut microbiota in predicting pathologic response after neoadjuvant chemoradiotherapy combined PD-1 antibody given to patients with locally advanced rectal cancer.

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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long course radiotherapy + capecitabine + PD-1 monoclonal antibody

long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer

long course radiotherapy + capecitabine + PD-1 monoclonal antibody

Intervention Type COMBINATION_PRODUCT

long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer

Interventions

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long course radiotherapy + capecitabine + PD-1 monoclonal antibody

long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
* Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0)；Tumor distal location ≤ 7 cm from anal verge (MRI diagnosed);
* Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
* Physical and viscera function of patients can withstand major abdominal surgery;
* Patients are willing and able to follow the study protocol during the study;
* Patients give consent to the use of blood and pathological specimens for study;
* Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.

Exclusion Criteria

* Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
* Patients underwent major surgery within 4 weeks prior to study treatment;
* Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
* Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
* Patients who are allergic to any of the ingredients under study;
* Patients with severe concomitant diseases with estimated survival ≤ 5 years;
* Patients with present or previous moderate or severe liver and kidney damage presently or previously;
* Patients have received other study medications or any immunotherapy currently or in the past;
* Patients preparing for or previously received organ or bone marrow transplant;
* Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
* Patients with congenital or acquired immune deficiency (such as HIV infection);
* If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
* Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
* Pregnant or lactating women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No