NIPH Clinical Trials Search

Kobe ICC study (IHCC PRT+GCD)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	unresectable intrahepatic cholangiocarcinoma
Date of first enrollment	17/12/2025
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	Durvalumab Gemcitabine Cisplatin Particle therapy, Proton or carbon ion therapy

Outcome(s)

Primary Outcome	Adverse events (AE) of Grade 3 or higher, as defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), on treatment
Secondary Outcome	Effectiveness endpoints 1) Tumor diameter of the irradiated lesions of particle therapy 2) Tumor diameter of the Non-irradiated lesions of particle therapy 3) Overall Survival 4) Progression Free Survival Safety endpoints 1) Adverse event (any grade)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Histologically diagnosed, untreated intrahepatic cholangiocarcinoma 2) Diagnosed as unresectable intrahepatic cholangiocarcinoma with measurable disease as per RECIST ver1.1. 3) Absence of distant metastasis (regional lymph node metastasis will be permitted to participate) 4) a patient with unresectable intrahepatic bile duct cancer who is a candidate for particle beam therapy Body weight more than 30kg 5) Adequate normal organ and marrow function as defined below: Hemoglobin 9.0 g/dL and more than 9.0 g/dL Absolute neutrophil count (ANC) 1.0 x 109 /L and more than 1.0 x 109 /L Platelet count 75 x 109/L and more than 75 x 109/L Serum bilirubin1.5 x and less than 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilberts syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. AST (SGOT)/ALT (SGPT) 2.5 and less than 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be 5x ULN and less than 5x ULN Calculated creatinine CL more than 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)), Females: Creatinine CL (mL/min) = ((Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL))) x 0.85 6) An Eastern Cooperative Oncology Group/World Health Organization Performance Status (ECOG/WHO PS) score of 0 or 1 at the time of registration 7) 18 years or older at the registration 8) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Exclude criteria	Patients should not enter the study if any of the following exclusion criteria are fulfilled. 1) Patients with multiple cancers. However, patients with multiple cancers, except for who have no signs of recurrence for at least 5 years or more than 5 years after completion of treatment and patients with epithelial cancer or endoscopically resectable gastrointestinal cancer within 5 years will be eligible for enrollment. Prostate and breast cancers treated with endocrine therapy alone are also eligible 2)The presence or history of autoimmune or inflammatory diseases. 3)Presence of active infectious diseases such as tuberculosis and human immunodeficiency virus (HIV). 4)Presence of brain metastases or spinal cord compression, including asymptomatic and appropriately treated diseases. 5)History of allogenic organ transplantation. 6)Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 7)Patients with the following poorly controlled comorbidities: - Unhealed or active infection - Symptomatic congestive heart failure, hypertension, unstable angina, or arrhythmia - Patients scheduled to undergo major surgery (as defined by the principal investigator, etc.) within 28 days prior to the first dose of study drug - Patients currently receiving or scheduled to receive immunosuppressants within 14 days prior to the first dose of study drug (excluding intranasal, inhaled, or topical steroids, local steroid injections, prednisone* 10 mg/day or equivalent systemic steroids, and steroid pretreatment for hypersensitivity reactions) 8)Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Registration is not possible for HBV-DNA positive. 9)Receipt of live attenuated vaccine within 30 days prior to the first dose of protocol treatment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving protocol treatment and up to 90days after the last dose of protocol treatment. 10)Patients with a history of the following cancer treatments: - Patients with a history of immunotherapy using other anti-PD-1 antibodies, anti-PD-1 antibodies, or anti-CTLA-4 antibodies, etc. - Patients currently receiving any chemotherapy, investigational drug, biological therapy, or hormonal therapy for cancer treatment 11)Participation in another clinical study with Durvalumab, Cisplatin, or Gemcitabine as an investigational product during the last 6 months. 12)Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 13) Pregnant or lactating women, or male or female patients of reproductive potential who are not willing to use effective contraception from screening through 180 days after the last dose of gemcitabine/cisplatin or 90 days after the last dose of durvalumab monotherapy. 14)Any concurrent chemotherapy, use of the same drugs as those evaluated in this study (Gemcitabine, Cisplatin, or Durvalumab), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. (15) Patients who are judged by the principal investigator or co-investigator to be inappropriate for participation in this study