Actively Recruiting
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-04
204
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.
CONDITIONS
Official Title
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
X
Xinyu Bi, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here