Clinical trial · Interventional
A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
NCT01297998CI-TRIAL-00030416completedPhase 1ClinicalTrials.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)
To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine , cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine , cisplatin
- interventionNames
- Drug: gemcitabine , cisplatin
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)
- description
- To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Secondary outcomes (1)
- measure
- Number of Participants with dose limiting toxicity
- timeFrame
- At the end of adjuvant chemotherapy (6 months)
- description
- Dose limiting toxicity is defined as follows 1. Grade 4 neutropenia, thrombocytopenia 2. Grade 3 or 4 febrile neutropenia 3. Grade 3 or 4 non-hematological adverse events unless unresponsive to treatment 4. Any adverse events resulting in interruption of dosing on day 8 in both the two courses 5. Any adverse events resulting in dose modification or delay of longer than 2 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biliary tract cancer (BTC) with more than stage IB 2. BTC undergoing R0 or R1 resection without major hepatectomy 3. Older than 20 years old 4. PS0 or 1 5. No treatment other than surgery 6. No dysfunction of main organs 7. Possible oral intake 8. Treatment start; after 4 weeks and within 12 weeks after surgery 9. Obtained written informed consent Exclusion Criteria: 1. Patients with resection of major hepatectomy 2. Patients with double cancers 3. Patients having severe allergy 4. Patients with severe organ dysfunction 5. Patients with active infectious disease 6. Pregnancy 7. Patients with severe psychological disease 8. Patients seem inadequate for this study by investigators
References
Publications (1)
- DERIVEDToyoda M, Ajiki T, Fujiwara Y, Nagano H, Kobayashi S, Sakai D, Hatano E, Kanai M, Nakamori S, Miyamoto A, Tsuji A, Kaihara S, Ikoma H, Takemura S, Toyokawa H, Terajima H, Morita S, Ioka T. Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004). Cancer Chemother Pharmacol. 2014 Jun;73(6):1295-301. doi: 10.1007/s00280-014-2431-y. Epub 2014 Mar 11. PMID 24614947