By InvitationEarly Phase 1

MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis

China10 participantsStarted 2024-07-01

Plain-language summary

Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
✓. Age 18-80.
✓. Pathological examination confirmed colorectal adenocarcinoma.
✓. For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):
✓. Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
✓. There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
✓. Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
✓. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.

Exclusion criteria

What they're measuring

ORR

Timeframe: Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Trial details

NCT IDNCT06434376

SponsorSecond Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

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