Adjuvant Therapy for Stage II/III Cholangiocarcinoma Based on 3D-PTA Susceptibility Testing: A Prospective, Multicenter, Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 98
- Primary Endpoint
- 12-month PFS rate.
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •Liver/kidney function: Serum creatinine (SCr) ≤1.5×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤2×ULN; AST/ALT ≤3×ULN; urine protein \<2+ (if ≥2+, 24-hour urine protein ≤1 g); Biliary drainage: Adequate surgical drainage, no signs of infection;
- •Normal coagulation function, no active bleeding or thrombotic disease:INR ≤1.5×ULN, APTT ≤1.5×ULN, PT ≤1.5×ULN;
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;
- •Patients with any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism; patients with vitiligo or childhood asthma that has been completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for medical intervention due to asthma cannot be included);
- •Patients using immunosuppressants or systemic/absorbable local corticosteroids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent) and continuing use within 2 weeks prior to enrollment;
Arms & Interventions
Control group: Capecitabine
Intervention: capecitabine alone as adjuvant treatment (Drug)
Outcomes
Primary Outcomes
12-month PFS rate.
Time Frame: 12-month
12-month PFS rate.
Secondary Outcomes
- median Recurrence-Free Survival（mRFS）(12-month)
- median Overall Survival（mOS）(12-month)
Investigators
Lu Wang, MD, PhD
Professor
Fudan University