Clinical trial · Interventional
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
NCT01859728CI-TRIAL-00031239GAMBITunknownPhase 2ClinicalTrials.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 evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
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 Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IP (irinotecan and cisplatin)
- description
- Irinotecan 65mg/m² D1 and D8 q21 days plus Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
- interventionNames
- Drug: Irinotecan
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- GC (gemcitabine and cisplatin)
- description
- Gemcitabine 1000mg/m² D1 and D8 every 21 days plus cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity, with standard hydration and antiemetics.
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy-proven gallbladder or biliary tract cancer; * Recurrent, metastatic or unresectable disease; * Chemo-naïve. * Not candidates to curative-intent treatment, such as surgery or radiation-therapy; * Measurable disease according to RECIST 1.1; * ECOG 0-2; * Adequate hematologic and biochemistry tests; * Creatinine clearance \>= 60ml/min. Exclusion Criteria: * Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan; * Chronic immunosuppressive therapy; * Known CNS metastasis; * Previous diagnosis of other cancer; * Chronic or acute active infection, except asymptomatic HIV infection; * Active bleeding; * Any severe medical condition; * Pregnant or lactating women, or with childbearing potential;
References
Publications (0)
Data not yet available
No reference posted for this study.