Not Yet RecruitingNot Applicable

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

38 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. Subjects volunteer to join the study and could complete the signing of the informed consent form, and had good compliance;
✓. Age ≥ 18 years old and\<80 years old (when signing the informed consent form);
✓. ECOG score 0-1;
✓. Resectable rectal cancer was confirmed by pathological diagnosis (pathology/cytology) and imaging;
✓. The clinical TNM stage is T3-4N0M0 or TanyN+M0;
✓. The distance from the lower edge of the tumor to the lower edge of the anus is ≤ 10cm;
✓. Patients who need routine neoadjuvant therapy after evaluation;
✓. dMMR or MSI-H was detected by immunohistochemistry/PCR;

Exclusion criteria

✕. 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;
✕. Subjects with any severe and/or uncontrollable disease. include:
✕. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
✕. Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (NYHA classification);
✕. Active or uncontrolled serious infection (≥ CTCAE level 2 infection) requiring systemic anti bacterial, anti fungal or anti-virus treatment, including tuberculosis infection. Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; hepatitis C reference: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide antiviral treatment, it is lower than the above criteria, it can be included in the group); Chronic hepatitis B virus carriers, HBV DNA\<2000 IU/ml, must receive antiviral treatment at the same time during the trial to be included in the group;
✕. Renal failure requiring hemodialysis or peritoneal dialysis;
✕. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
✕. Poor control of diabetes (fasting blood glucose \[FBG\]\>10mmol/L);

What they're measuring

cCR and pCR rates

Timeframe: 1-year

Trial details

NCT IDNCT05645094

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-01

Contact for this trial

Yaqi Li, PhD

+8615902194450 yaqili702@hotmail.com

View on ClinicalTrials.gov More Locally Advanced Rectal Carcinoma trials