Adjuvant Chemotherapy for BTC Based on 3D-PTA

NCT07296666 | Not Yet Recruiting Phase 2

• 1 other identifier: GWK-2025-008
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholangiocarcinoma

Keywords

BTC

Outcome Measures

Primary Outcomes (1)

• 12-month PFS rate.

  12-month PFS rate.

  12-month

Secondary Outcomes (2)

• median Recurrence-Free Survival（mRFS）

  12-month

• median Overall Survival（mOS）

  12-month

Study Arms (2)

Treatment group: Capecitabine + 3D-PTA-selected chemotherapy drugs (conventional dosage)

EXPERIMENTAL

Drug: Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone).

Control group: Capecitabine

ACTIVE COMPARATOR

Drug: capecitabine alone as adjuvant treatment

Interventions

capecitabine alone as adjuvant treatment DRUG

capecitabine alone as adjuvant treatment

Control group: Capecitabine

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.

Treatment group: Capecitabine + 3D-PTA-selected chemotherapy drugs (conventional dosage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Contraception:
• Non-surgically sterilized or reproductive-age patients must use medically approved contraception (e.g., IUD, oral contraceptives, condoms) during and for 3 months after treatment;
• Reproductive-age females must have negative serum/urine pregnancy test (HCG) within 7 days before enrollment and must not be breastfeeding;
• Reproductive-age males must agree to use contraception with partners during and for 3 months after treatment;
• Voluntary participation, good compliance, and willingness to follow up for safety and survival assessments.

You may not qualify if:

• 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;
• Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage;
• Poorly controlled cardiac symptoms or diseases, such as:
• NYHA Class II or higher heart failure,
• unstable angina,
• myocardial infarction within 1 year,

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Drug Therapy; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lu Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang

CONTACT

86-13601678615; w.lr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share