Adjuvant Chemotherapy for BTC Based on 3D-PTA

Sponsor
Fudan University
Study ID
NCT07296666
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone). — DRUG
    Chemotherapy combined with capecitabine (including capecitabine monotherapy) guided by 3D-PTA drug sensitivity testing versus capecitabine alone as adjuvant treatment.
  • capecitabine alone as adjuvant treatment — DRUG
    capecitabine alone as adjuvant treatment

Study Details

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.

Key Dates

First listed
Dec 22, 2025
Start date
Dec 31, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group: Capecitabine + 3D-PTA-selected chemotherapy drugs (conventional dosage)
  • Active Comparator: Control group: Capecitabine

Primary Outcome Measure

12-month PFS rate. [ Time Frame: 12-month ]

Central Contacts

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