Clinical trial · Interventional
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors
Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study
- 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)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
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 |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A - Gemcitabine
- description
- Gemcitabine alone
- interventionNames
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- B - Gemcitabine and Cisplatin
- description
- Gemcitabine and Cisplatin
- interventionNames
- Drug: cisplatin
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From date of randomisation till date of death or last date of follow-up (up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma * Intra- or extra-hepatic disease allowed * Unresectable locally advanced, recurrent, or metastatic disease * No brain metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 1.5 times ULN * Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) * Adequate biliary drainage * No unresolved biliary tract obstruction Renal * Creatinine \< 1.5 times ULN * Urea \< 1.5 times ULN * Glomerular filtration rate (GFR) ≥ 45 mL/min * If GFR \< 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active, uncontrolled infection * No other severe or uncontrolled systemic disease * No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection * No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy * At least 6 months since prior adjuvant chemotherapy * No prior gemcitabine hydrochloride * No prior cisplatin * No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy * Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery * Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other * Recovered from all prior therapies * Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease * PDT must have been completed ≥ 4 weeks ago * At least 4 weeks since prior investigational agents * No other concurrent, curative anticancer therapy
References
Publications (2)
- RESULTValle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721. PMID 20375404
- DERIVEDLamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, Palmer DH, Valle JW, Bridgewater J. Advanced extrahepatic cholangiocarcinoma and gallbladder cancer: Post-hoc analysis of the ABC-01, -02 and -03 clinical trials. JHEP Rep. 2026 Jul;8(7):101833. doi: 10.1016/j.jhepr.2026.101833. Epub 2026 Mar 24. PMID 41887529