An Early Phase 1 interventional study of Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology in Colorectal Cancer, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Early Phase 1, Interventional, and Treatment
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
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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):
a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check \< 12 nodes
Exclusion Criteria:
Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:
Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology
Blood samples were collected for MRD detection within one month (week 3) after colorectal cancer surgery, and MRD-positive patients were selected for routine chemotherapy (course of 6 months). Blood and tumor tissue samples of enrolled patients were collected, and relevant clinical data were recorded. The whole exon and expression profile of surgical tumor tissue samples were sequenced, neoantigens were analyzed, and immunomodulators were prepared. After the preparation of individualized immunomodulators, combined treatment was performed simultaneously with chemotherapy. During the treatment process, patients' response to treatment and survival were observed, and tumor load, ctDNA changes, imaging and other indicators before and after treatment were compared. To evaluate the efficacy of immunotherapy.
ORR
Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
Time frame: 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
PFS
Observe and evaluate the progression free survival (PFS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technolog
Time frame: 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
OS
Observe and evaluate the overall survival(OS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technology
Time frame: 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
Plan to share: No — publication
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital of Wenzhou Medical University