A phase 2 trial for patients with locally advanced or metastatic bile duct cancer investigating treatment with cisplatin and gemcitabine with or without tocilizumab.

Phase 1

• Conditions: First-line treatment in patients with locally advanced or metastatic biliary tract cancer, inoperable due to extension of the disease.; MedDRA version: 25.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10008596Term: Cholangiocarcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10074878Term: Hilar cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10074879Term: Extrahepatic cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10077846Term: Cholangiocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004826-27-DK
• Lead Sponsor: Department of Oncology, Herlev & Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-06
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Signed informed consent. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
• Male or non-pregnant, non-lactating females who are =18 years of age at the time of signing the informed consent form (ICF)
• Histological or cytological biliary tract adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed
• Unresectable locally advanced or metastatic biliary tract carcinoma
• ECOG/WHO Performance Status (PS) 0-1
• = 4 weeks since prior major surgery, = 2 weeks since prior minor surgery
• Measurable disease using the RECIST1.1 criteria, defined as lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter = 20 mm with conventional techniques or = 10 mm with spiral CT scan or MRI
• Fertile women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must use highly effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or vasectomized partner) while on study IP; and for 3 months following the last dose of chemotherapy; and has negative serum pregnancy test (ß -hCG) result at screening
• Male subjects: must practice true abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
•Acceptable hematology parameters defined as:
•Absolute neutrophil count (ANC) = 1.5 x 10?/L
•Platelet count = 100 x 10?/L
•Acceptable liver function with:
•Serum bilirubin < 1.5 x upper limit of normal (ULN)
•AST and ALT <2.5 x ULN (or 5 x ULN in the presence of liver metastases)
•Acceptable renal function with an eGFR = 60 mL/min/1,73m2
•Subjects must have signed and dated a CHOCA approved written informed consent form in accordance with regulatory and institutional guidelines.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 83

Exclusion Criteria

• Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia
• Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumor with disease-free survival of = 5 years
• History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
•Active infection requiring antibiotics within 2 weeks before the study inclusion
•Concurrent congestive heart failure NYHA (class III - IV)
•Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
•Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal conditions associated with risk of perforation
•Hearing impairment grade = 2 according to CTCAE v 5.0
•Peripheral neuropathy grade = 2 according to CTCAE v 5.0.
• Evidence of active tuberculosis (TB), or suspected latent TB based on medical history (e.g. history of untreated TB or TB exposure) without a subsequent negative TB test
• Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
• No known or suspected allergy to the investigational agents or any agents given in association with this trial
• Pregnant or lactating women
• Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
• Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified