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Active, not recruitingNCT02403505CEA+RC-BCGUpdated May 28, 2026

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer

A Phase 1 interventional study of CEA protein antigen plus BCG Vaccine Mix for percutaneous use in Rectal Cancer, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. Active, not recruiting at 1 site in United States. Open to participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
24 Years to 64 Years
Sex
All
01

Study summary

Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.

  1. Treat CEA positive rectal cancer via Trained Immunity.
  2. Activate human CEA Protein Antigen Presentation Reaction.
  3. The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.
Read the detailed description
  • Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients
  • 20 CEA Positive Rectal Cancer Patients
  • Positive testing CEA by blood-drawing
  • TB negative participant is negative IGRA blood test with TB antigens
  • Clinical Rectal Cancer Diagnosis Stage 0 - IIA
  • Clinical Rectal Cancer Diagnosis without symptoms
  • Clinical Rectal Cancer Diagnosis without metastasis
  • CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
  • By the percutaneous route with the multiple puncture device
  • Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
  • Our trial duration will be 12-week duration
02

Conditions studied

  • Rectal Cancer

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Keywords

  • CEA
  • Antigen Presentation
  • APC
  • Trained Immunity
  • Innate Immune Memory
  • Rectal Cancer
03

In context

Rectal Neoplasms

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's planned enrollment of 20 is below the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients.

20 CEA Positive Rectal Cancer Patients

Inclusion criteria

Inclusion Criteria:

  • Clinical Rectal Cancer Diagnosis Stage 0 - IIA
  • Clinical Rectal Cancer Diagnosis without symptoms
  • Clinical Rectal Cancer Diagnosis without
  • Positive testing CEA by blood-drawing
  • TB negative participant is negative IGRA blood test with TB antigens.

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Thrombosis
  • Allergy
  • TB positive participant is positive IGRA blood test with TB antigens.
  • Symptoms of rectal cancer
  • of rectal cancer
  • Evidence of critical illness
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity

    CEA protein antigen 0.05 mg add into BCG Organism 50 MG

    Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use

Interventions

  • BiologicalCEA protein antigen plus BCG Vaccine Mix for percutaneous use

    * By the percutaneous route with the multiple puncture device * CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix

    Also known as: CEA protein antigen plus BCG Organism Mix

06

What researchers measure

Primary outcomes

  1. 20 Rectal Cancer Participants with CEA blood test

    Positive testing CEA by blood-drawing

    Time frame: Duration up to 90 days

  2. 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen

    Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days

    Time frame: Duration up to 90 days

  3. 20 Rectal Cancer Participants with IGRA blood test with TB antigens

    * Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days

    Time frame: Duration up to 90 days

07

Study locations

1 site
  • Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
    Rockville, Maryland 20853, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02403505
Lead sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborators
UnitedHealthcare
Responsible party
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair (M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc) — Sponsor-investigator
First posted
Mar 31, 2015
Start date
Dec 28, 2021
Primary completion
Nov 28, 2026 (estimated)
Completion
Dec 28, 2026 (estimated)
Last update
May 28, 2026

Study contacts

HAN XU, MD/PhD/FAPCR
study chair · IRB00009424--NPI-1831468511
HAN XU, MD/PhD/FAPCR
study director · IORG0007849--NPI-1023387701
HAN XU, MD/PhD/FAPCR
principal investigator · IORG0007849--FWA00015357

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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