Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in Resectable iCCA (NCT06569225) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in Resectable iCCA
Canada40 participantsStarted 2024-12-15
Plain-language summary
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials \[(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient must be capable of providing written informed consent.
✓. Complete surgical resection of the tumor must be achievable\*. Resection should include a portal lymphadenectomy as per standard of care.
✓. No prior cytotoxic, targeted or immune therapy
✓. Have provided archival tumor tissue sample or preferably freshly obtained biopsy of a tumor lesion not previously irradiated for mandatory pre-treatment evaluation (baseline).
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
✓. Estimated life expectancy \>3 months
Exclusion criteria
✕0. If underlying liver cirrhosis, Childs Pugh score of 5 or 6
✕
What they're measuring
1
Major pathological response (MPR), defined as >70% tumor necrosis
✕2. Patients with HBV infection, which is characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice, to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL) prior to study entry. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\<10 IU/ml or under limit of detection per local lab standard) do not require anti-viral therapy prior to study entry. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU/ml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
✕3. Patients with HCV infection must have management of this disease per local institutional practice throughout the study. HCV diagnosis is characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrollment.
✕4. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients.
✕5. Adequate normal organ and marrow function as defined below within screening period:
✕6. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
✕. Locally unresectable tumor or metastatic disease: