Using PDOX to guide chemotherapy after liver cancer surgery
Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
This study is testing if using a special lab-grown model of liver cancer can help doctors choose the best chemotherapy for patients after they have surgery for liver cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05766605 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the clinical feasibility of PDOX (Patient-Derived Orthotopic Xenograft) results in determining the use of interventional chemotherapy following radical surgery for primary liver cancer. Patients who have undergone radical surgical resection for hepatocellular carcinoma will be enrolled and treated with various chemotherapy agents, including Oxaliplatin and Doxorubicin. The primary endpoint is the one-year disease-free survival rate, while secondary endpoints include the assessment of adverse events. Data will be collected from patients receiving PDOX to inform treatment decisions post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have undergone radical surgical resection for hepatocellular carcinoma and meet specific health criteria.
Not a fit: Patients with recurrent liver cancer or those with existing distant metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve disease-free survival rates for patients with hepatocellular carcinoma after surgery.
How similar studies have performed: While the use of PDOX in guiding chemotherapy is a novel approach, similar studies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Undergone radical surgical resection. 2. Aged 18-75. 3. Patients voluntarily cooperated with the study and signed an informed consent form. 4. Histopathologically diagnosed hepatocellular carcinoma. 5. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery). 6. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites. 7. ECOG physical fitness status score of 0-1. 8. No serious heart, lung, or renal dysfunction Exclusion Criteria: 1. Unable to provide specimens for PDOX testing. 2. Patients with recurrent liver cancer. 3. Developing two or more types of tumors simultaneously. 4. Patients with existing extrahepatic distant metastases. 5. Treatment with other experimental drugs or other interventions after radical resection. 6. Patients with other malignant tumors that have not been cured within 5 years. 7. Patients with non-radical resections (R1 and R2 resections). 8. Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery. 9. Died within 1 month after surgery.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mingxin Pan, Prof.
- Email: pmxwxy@sohu.com
- Phone: +8618928918216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.