MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer

Not Applicable

Recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Other: MiniPDX group; Drug: Capecitabine

• Registration Number: NCT07156058
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.

Detailed Description

Biliary tract cancer (BTC) is the most common primary malignancy of the biliary tract. Currently, surgery provides the only ray of hope for the management of BTC, however, the disease is progressing rapidly, lacking of obvious symptoms in its early stages, with metastases to lymph nodes. Only 20-30% of patients are eligible for surgical resection with curative intent. In addition, the treatment remains difficult because of the lack of effective chemotherapeutic agents and the combined regimens for reference.

In this study, fresh tumor samples generated directly from patients will be used for a MiniPDX test and inoculated in mice subcutaneously. The candidate drugs or regimens can be tested in mice to determine the best treatment for that specific patient after surgery.

The study aims to evaluate the efficacy and accuracy of MiniPDX assays for antitumor chemotherapeutics.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-09-13
• Primary Completion: 2025-08-31
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiniPDX group	MiniPDX group	102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays.
Treatment of Physician's Choice (TPC)	Capecitabine	TPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy.

Primary Outcome Measures

Name	Time	Method
Relapse-Free Survival (RFS)	Through study completion, an expected average of 2 year.	The interval from surgery to diagnosis of recurrence in the patients enrolled.

Secondary Outcome Measures

Name	Time	Method
Non-recurrence after radical surgery for BTC in 2 years	Through study completion, an expected average of 2 year.	The ratio of patients with BTC after radical surgery without recurrence in 2 years.
Overall Survival (OS)	Through study completion, an expected average of 2 year.	The interval from randomization until death, whichever comes first.
Event-Free Survival (EFS)	Through study completion, an expected average of 2 year.	The time from randomization to initial occurrence (including local recurrence, metastasis, second primary cancer, death or any cause among the above), whichever comes first.
Quality of Life (QOL)	Through study completion, an expected average of 2 year.	Assessed by the EORTC QLQ-C30 for patients over 16 years old) or the Pediatric Quality of Life Inventory (PedsQL) for patients under 16 years old.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China