Not Yet RecruitingPhase 2

Adjuvant Chemotherapy for BTC Based on 3D-PTA

98 participantsStarted 2025-12

Plain-language summary

This is a prospective, open-label, controlled, multicenter clinical study designed to observe and evaluate the efficacy and safety of chemotherapy (including capecitabine monotherapy) guided by 3D-PTA drug sensitivity testing versus capecitabine monotherapy as adjuvant treatment in patients with stage II/III cholangiocarcinoma after surgery.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signing of written informed consent prior to participation;
✓. Age ≥18 years, regardless of sex;
✓. Histologically confirmed stage II/III biliary tract malignancies (including intrahepatic cholangiocarcinoma, extrahepatic/hilar cholangiocarcinoma, gallbladder cancer, distal bile duct cancer, or ampullary cancer);
✓. Must have undergone radical resection (R0/R1), including liver/pancreatic resection or, less commonly, both;
✓. ECOG performance status (PS) score: 0-1;
✓. Expected survival \>6 months and ability to tolerate combined therapy;
✓. Adequate organ function (without blood component or growth factor support within 14 days):
✓. Hematology: Neutrophils ≥1,500/mm³, platelets ≥100,000/mm³, hemoglobin ≥9 g/dL;

Exclusion criteria

✕. Early-stage BTC patients;
✕. Pancreatic cancer patients;
✕. Patients who have undergone other postoperative radiotherapy/chemotherapy; preoperative chemoradiotherapy followed by radical resection, but postoperative pathology still indicates Stage II/III disease is allowed;
✕. Incomplete surgical recovery or unresolved biliary obstruction;
✕. Patients with radiologically confirmed distant metastasis;
✕. Patients with a history of or concurrent other malignancies (except for cured basal cell carcinoma of the skin and in-situ carcinoma of other sites);
✕. Known allergies to any component of the investigational drug;
✕. Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction;

What they're measuring

12-month PFS rate.

Timeframe: 12-month

Trial details

NCT IDNCT07296666

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Lu Wang

86-13601678615 w.lr@hotmail.com

View on ClinicalTrials.gov More Cholangiocarcinoma trials