Clinical trial · Interventional
Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer
Biomarker-oriented Study of Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer
- 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)
\<Research Hypothesis\> The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered. The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer. \<Purpose of the study\> To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.
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 Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab/Tremelimumab+chemotherapy
- description
- Durvalumab and Tremelimumab in combination with gemcitabine/cisplatin.
- interventionNames
- Drug: Durvalumab
- Drug: Tremelimumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 6 weeks
- description
- According to RECIST v1.1 criteria
Secondary outcomes (7)
- measure
- Disease control rate
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer * Unresectable or recurrent * chemotherapy -naïve for their unresectable or recurrent cancer (Previous expose to adjuvant chemotherapy is allowed) * should have measurable lesion * ECOG 0, 1 * Without previous expose to immune-oncology agents including anti-CTLA4, anti-PD1, anti-PDL1, etc * Adequate organ function : ANC\>1500/mm3, platelet\>100K/mm3, HgB\>9 g/Dl, bilirubin\<1.5 x ULN, ALT/AST\<2.5 X UNL, (in case of liver metastasis, \<5 Xunl), Cr\<1.5 mg/Dl * Informed consent Exclusion Criteria: * Previous treatment for unresectable or recurrent cancer * Under immunosuppressive agents higher than equivalent dose of prednisone 10mg/day * Uncontrolled disease such as current active infection, congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease * Current active pulmonary tuberculosis * Current active hepatitis B or hepatitis C (simple carrier is allowed) * anti-HIV (+) * Pregnant, breast-feeding women
References
Publications (1)
- DERIVEDOh DY, Lee KH, Lee DW, Yoon J, Kim TY, Bang JH, Nam AR, Oh KS, Kim JM, Lee Y, Guthrie V, McCoon P, Li W, Wu S, Zhang Q, Rebelatto MC, Kim JW. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):522-532. doi: 10.1016/S2468-1253(22)00043-7. Epub 2022 Mar 9. PMID 35278356