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Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer: a Single-arm, Prospective Trial

NCT05645094•Fudan University

Summary

This is a single center, prospective, single arm clinical trial to evaluate the efficacy and safety of Envafolimab as a neoadjuvant therapy for resectable and locally advanced dMMR or MSI-H rectal cancer.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects volunteer to join the study and could complete the signing of the informed consent form, and had good compliance;
•2. Age ≥ 18 years old and\<80 years old (when signing the informed consent form);
•3. ECOG score 0-1;
•4. Resectable rectal cancer was confirmed by pathological diagnosis (pathology/cytology) and imaging;
•5. The clinical TNM stage is T3-4N0M0 or TanyN+M0;
•6. The distance from the lower edge of the tumor to the lower edge of the anus is ≤ 10cm;
•7. Patients who need routine neoadjuvant therapy after evaluation;
•8. dMMR or MSI-H was detected by immunohistochemistry/PCR;
•9. Patients did not received immunotherapy, chemotherapy, targeted therapy or radiotherapy for rectal cancer in the past;
•10. The expected life span exceeds 3 months;
+28 more criteria

Exclusion Criteria

•1. Patients with active autoimmune diseases or autoimmune diseases that may recur are as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and those who have previously undergone thyroid surgery cannot be included; Subjects who suffer from vitiligo or asthma in childhood has completely alleviated, and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators was excluded;
•2. Subjects with any severe and/or uncontrollable disease. include:
•1. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
•2. Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (NYHA classification);

Key Dates

Start Date

January 1, 2023

Primary Completion Date

June 1, 2023

Completion Date

June 1, 2026

Last Updated

December 13, 2022

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal CarcinomaMSI-High

Interventions

Envafolimab

DRUG

Contacts

Yaqi Li, PhD

CONTACT

+8615902194450 yaqili702@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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