MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Xinyu Bi, M.D.
beexy1971@163.com
13911792177
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 204
Treatments
Experimental: MiniPDX group
102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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