NCT07296666

Adjuvant Chemotherapy for BTC Based on 3D-PTA

Adjuvant Therapy for Stage II/III Cholangiocarcinoma Based on 3D-PTA Susceptibility Testing: A Prospective, Multicenter, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All participants underwent baseline disease assessment, including radiological evaluation within 14 days before treatment initiation. The study compared capecitabine combined with 3D-PTA-selected chemotherapy drugs (administered at standard doses) versus capecitabine monotherapy. Participants received study drugs on Day 1 of each cycle for 8 cycles. Tumor efficacy evaluation, vital signs, ECOG performance status (PS) score, physical examination, and quality of life (QoL) assessments were conducted every 9 weeks after the first dose until disease progression, unacceptable toxicity, or participant withdrawal. Adverse event (AE) monitoring and concomitant medication documentation were performed continuously from treatment initiation through 30 days post-treatment. Follow-up included tumor efficacy evaluation and QoL assessment every 6 months, with survival follow-up for participants experiencing disease recurrence or metastasis.

Conditions

• Cholangiocarcinoma

Interventions

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

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-12-22
• Last updated: 2025-12-22