Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients. Phase: Phase 2Accepts Healthy Volunteers? No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Antibodies, Monoclonal; Cisplatin; Durvalumab; Gemcitabine; Tremelimumab

Criteria

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