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Human tumor xenograft microtransplantation models (MPDX) as precision medicine biomarkers in colorectal cancer: an exploratory study on the correlation between drug sensitivity and clinical treatment outcomes

Human tumor xenograft microtransplantation models (MPDX) as precision medicine biomarkers in colorectal cancer: an exploratory study on the correlation between drug sensitivity and clinical treatment outcomes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109097
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

MPDX constructed from the patients tumor sample:Oxaliplatin, Leucovorin, 5-Fluorouracil
MPDX constructed from the patients tumor sample: Irinotecan + Calcium Leucovorin + 5-Fluorouracil
MPDX constructed from the patients tumor sample:Oxaliplatin, Leucovorin, 5-Fluorouracil, Cetuximab
MPDX constructed from the patients tumor sample:Regorafenib

Sponsors

Tianjin People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–75 years, regardless of sex. 2. Histopathologically confirmed colorectal cancer requiring systemic anticancer therapy. 3. Availability of fresh tumor tissue obtainable via surgical resection or biopsy. 4. Presence of measurable lesions according to RECIST 1.1 criteria, evaluable by CT or MRI. 5. ECOG performance status 0–2, with an expected survival of >= 3 months. 6. For postoperative patients: prior failure of anticancer therapy (chemotherapy and/or targeted therapy) must be >= 4 weeks before enrollment (date of informed consent), and all related adverse events must have resolved to <= Grade I per NCI-CTCAE v5.0. 7. Patients must voluntarily participate, provide written informed consent, demonstrate good compliance, and be willing to actively undergo treatment and adhere to follow-up schedules.

Exclusion criteria

Exclusion criteria: 1. Currently participating in another drug clinical trial. 2. Patients with hepatic, renal, or bone marrow hematopoietic function not meeting the requirements for chemotherapy. 3. Patients unwilling to receive subsequent chemotherapy with anticancer drugs or regimens recommended by the investigator based on the test results after prior treatment failure. 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Change in diameter of maximum liver metastases (according to RECIST 1.1);Objective Response Rate;

Secondary

MeasureTime frame
Disease Control Rate;Serum Tumor Marker;Safety Indicators;

Countries

China

Contacts

Public ContactYu Yongjun

Tianjin People's Hospital

yyj19820430@163.com+86 22 2755 7022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026