Status:
RECRUITING
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT07156058
Start Date
January 1 2023
End Date
December 31 2025
Last Update
September 4 2025
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021