Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in Resectable iCCA

Exclusion Criteria

• •1. Locally unresectable tumor or metastatic disease:
• •1. Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow
• •2. Radiological evidence of direct invasion into adjacent organs.
• •3. Radiological evidence of extrahepatic metastatic disease (except regional lymph nodes - stations 9 and 12
• •2. Contraindication to any of the study drugs
• •3. Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment
• •4. Are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or for a period of at least 5 half-lives of the respective drug/IMP (whichever is longer) before screening and during Screening for this trial.
• •5. Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• •6. Have a known additional malignancy that is progressing or has required active treatment within the past 2 years.
• •Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• •7. Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
• •8. Have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• •9. Have an active infection requiring systemic therapy (exception: HBV and HCV infection).
• •10. Have a history of Human Immunodeficiency Virus (HIV) (mandatory testing for HIV during screening is required).
• •11. Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •12. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient's preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.
• •Note: Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or not post menopausal.
• •Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• •* Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.
• •* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, or had chemotherapy-induced menopause with last menses \>1 year ago.
• •* Women who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible.
• •Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective (e.g., male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action \[excluding Cerazette/desogestrel, which is considered highly effective\]; and triphasic combined oral contraceptive pills). Serum levels of contraceptive hormones may be altered by concomitant use of other drugs. Therefore, drug interactions should always be considered when prescribing hormonal contraception; there could be a risk of contraceptive failure or other adverse effects.
• •13. Legal incapacity or limited legal capacity.