Clinical trial · Interventional
Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection
Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection
NCT03779035CI-TRIAL-00036209AdBTC-1unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gall Bladder Carcinoma | Gallbladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine plus Capecitabine
- description
- Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Gemcitabine
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine
- description
- Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct) * Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both * Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete * Must be able to start treatment within 12 weeks of surgery * No pancreatic or periampullary cancer * No mucosal gallbladder cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Urea \< 1.5 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * Glomerular filtration rate ≥ 60 mL/min (if \< 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA) * Hemoglobin ≥ 10 g/dL * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 3 times ULN * ALT and AST ≤ 5 times ULN * Adequate surgical biliary drainage with no evidence of infection * Not pregnant or nursing * Negative pregnancy test for women of childbearing age and childbearing potential * Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended * Must provide written informed consent * No history of other malignant diseases within the past 5 years * No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection * No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial * No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance * No other serious uncontrolled medical conditions * No unresolved biliary tree obstruction PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Completely recovered from prior surgery * No use of other investigational agents within 28 days prior to and during study treatment * No prior chemotherapy or radiotherapy for biliary tract cancer * No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.