MiniPDX-guided postoperative adjuvant therapy for biliary tract cancer

MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study

This will test whether using a MiniPDX drug-sensitivity test on a patient’s tumor can guide post-surgery chemotherapy for people with biliary tract cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07156058 on ClinicalTrials.gov

What this trial studies

After curative (R0) surgical resection, fresh tumor tissue from each patient is implanted subcutaneously into mice in a MiniPDX platform and exposed to candidate drugs or regimens. The MiniPDX results are used to select a postoperative adjuvant chemotherapy plan, with capecitabine included as a comparator intervention. The study measures how accurately the MiniPDX predicts drug responses and whether MiniPDX-guided therapy improves clinical outcomes. Follow-up includes standard clinical monitoring and laboratory tests to track recurrence and treatment tolerability.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed biliary tract cancer who underwent R0 resection, have ECOG 0–2, adequate organ function, and can tolerate combination treatment are ideal candidates.

Not a fit: Patients with unresectable disease, insufficient tumor tissue for MiniPDX, poor performance status, or major organ dysfunction are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, MiniPDX guidance could help personalize adjuvant chemotherapy to improve outcomes and avoid ineffective drugs.

How similar studies have performed: Patient-derived xenograft and organoid-guided therapies have shown promise in small series, but MiniPDX-based guidance remains relatively novel with limited large-scale validation.

Eligibility criteria

Inclusion Criteria:

1. histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection.
2. Ambulatory male or female. Age ≥ 18 years.
3. ECOG performance status between 0 and 2
4. Patients must be tolerated with combination treatment with life expectancy of greater than 6 months.
5. No dysfunction and bleeding tendency in main organs (heart, liver, brain and kidneys); No history of blood disease; No cardiac insufficiency or chest pain (medically uncontrollable). No myocardial infarction occurred within 12 months before the start of the study.
6. Subjects must have normal organ as defined below: Hb ≥80 g/L; ANC ≥1.5×109/L; Platelets ≥100×109/L; AL/AST ≤2.5 x institutional upper limit of normal; ALP ≤2.5 x ULN; Total bilirubin \<1.5 x ULN; Creatinine \<1 x ULN; Serum albumin ≥30g/L.
7. Women of child-bearing potential must agree to use adequate contraception (IUD, contraceptives or condoms) for the duration of study participation, and for 6 months after completion of study; Serum or urine pregnancy tests are negative within 7 days before study entry; men must agree to use adequate contraception for the duration of study participation, and for 6 months after completion of study.
8. Patients must be willing to and able to follow the protocol during study entry.
9. Patients must be willing to sign an informed consent and able to understand that anytime is all right to quit the study without loss.

Exclusion Criteria:

1. Prior chemotherapy or radiotherapy.
2. Patients are in other clinical trials.
3. Coagulation disorders, history of blood disease or serious (active) heart disease such as coronary heart disease with apparent symptom, congestive heart failure of NYHA Class II or more severe, serious heart rhythm controlled by medicaments, or the attack of myocardial infarction within 12 months.
4. Hepatic and renal insufficiency with apparent symptom.
5. Pregnant or lactating female, or women of child-bearing age who have a positive serum pregnancy test or no tests. Female subjects of non-reproductive potential with post-menopausal for ≥1 year.
6. Patients with multiple primary cancer, or brain or meningeal metastases.
7. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as judged by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medication
8. Patients who need immunotherapy for organ transplantation.
9. Patients with recurrent infections, or other uncontrolled accompanying diseases, or hepatic cirrhosis caused hepatic injury or chronic active hepatitis (ALT ≥2 ULN, AST ≥1.5 ULN, PT \>13 S or TB ≥2 ULN)
10. Moderate or severe kidney injury \[CrCl ≤50 ml/min (Cockcroft-Gault Equation)\], or creatinine \> ULN

Where this trial is running

Beijing

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xinyu Bi, M.D. — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xinyu Bi, M.D.

Conditions Biliary Tract Cancer