MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer

NCT07156058 | Recruiting DMC

• 1 other identifier: LC2022A04
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Relapse-Free Survival (RFS)

  The interval from surgery to diagnosis of recurrence in the patients enrolled.

  Through study completion, an expected average of 2 year.

Secondary Outcomes (4)

• Overall Survival (OS)

  Through study completion, an expected average of 2 year.

• Event-Free Survival (EFS)

  Through study completion, an expected average of 2 year.

• Non-recurrence after radical surgery for BTC in 2 years

  Through study completion, an expected average of 2 year.

• Quality of Life (QOL)

  Through study completion, an expected average of 2 year.

Study Arms (2)

MiniPDX group

EXPERIMENTAL

102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays.

Other: MiniPDX group

Treatment of Physician's Choice (TPC)

ACTIVE COMPARATOR

TPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy.

Drug: Capecitabine

Interventions

MiniPDX group OTHER

Personalized treatment for guided by mini-PDX. The MiniPDX test can provide drug sensitivity results in as little as 7 days. Drugs including but not limited to the following agents: capecitabine, gemcitabine + cis-platinum, gemcitabine + capecitabine, 5-FU + oxaliplatin, gemcitabine, 5-FU, capecitabine + cis-platinum, 5-FU + cis-platinum.

MiniPDX group

Capecitabine DRUG

Drug: Capecitabine

Treatment of Physician's Choice (TPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection.
• Ambulatory male or female. Age ≥ 18 years.
• ECOG performance status between 0 and 2
• Patients must be tolerated with combination treatment with life expectancy of greater than 6 months.
• 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.
• 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.
• 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.
• Patients must be willing to and able to follow the protocol during study entry.
• Patients must be willing to sign an informed consent and able to understand that anytime is all right to quit the study without loss.

You may not qualify if:

• Prior chemotherapy or radiotherapy.
• Patients are in other clinical trials.
• 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.
• Hepatic and renal insufficiency with apparent symptom.
• 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.
• Patients with multiple primary cancer, or brain or meningeal metastases.
• 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
• Patients who need immunotherapy for organ transplantation.
• 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)
• Moderate or severe kidney injury \[CrCl ≤50 ml/min (Cockcroft-Gault Equation)\], or creatinine \> ULN

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xinyu Bi, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyu Bi, M.D.

CONTACT

13911792177; beexy1971@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 4, 2025
• Study Start: January 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

CN (1)