MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
NCT ID: NCT07156058
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MiniPDX group
102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays.
MiniPDX group
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.
Treatment of Physician's Choice (TPC)
TPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy.
Capecitabine
Drug: Capecitabine
Interventions
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MiniPDX group
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.
Capecitabine
Drug: Capecitabine
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Xinyu Bi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xinyu Bi, M.D.
Role: primary
References
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Other Identifiers
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LC2022A04
Identifier Type: -
Identifier Source: org_study_id
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