Active — Not RecruitingPhase 2

Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Germany50 participantsStarted 2019-11-01

Plain-language summary

A multicenter Phase II, randomized, prospective, open-label Trial investigating the clinical impact on combining Specific Internal Radiotherapy (SIRT) with the PD1-L Inhibitor Durvalumab and the CTLA-4 Inhibitor Tremelimumab in patients with intrahepatic Biliary Tract Cancer

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Fully-informed written consent and locally required authorization (European Union \[EU\]: General Data Privacy Regulation (GDPR)) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
✓. Age ≥ 18 years.
✓. Histologically documented diagnosis of locally-advanced OR limited metasized intrahepatic BTC not amenable to curative treatment (tumor resection or ablation), specified as

Exclusion criteria

✕. Patients with prior chemotherapy and/or immunotherapy can be enrolled if ONE of the following criteria is met:
✕. Has been considered candidate for standard-of-care Y-90 SIRT therapy per Investigator decision and after prior consultation with the tumor board if available at site and does not display contraindications against SIRT.
✕. Performance status (PS) ≤ 1 (ECOG scale).
✕. Body weight \>30 kg
✕. At least one measurable site of disease as defined by RECIST 1.1 criteria.
✕. Adequate bone marrow and renal function
✕0. Adequate hepatic function (with stenting for any obstruction, if required)
✕1. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.

What they're measuring

Objective Response rate (ORR) according to RECIST 1.1

Timeframe: 20 months

Trial details

NCT IDNCT04238637

SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

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