Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
Second Line Therapy With Regorafenib and HAIC Compared to FOLFOX for Advanced Intrahepatic Cholangiocarcinoma
Verified date | September 2022 |
Source | Tianjin Medical University Cancer Institute and Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 25, 2025 |
Est. primary completion date | September 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Signed and dated IRB/IEC-approved Informed Consent. - Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the Intrahepatic Cholangiocarcinoma. - Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed). - Age 18-75 years - Karnofsky Performance Status > 50% - Estimated life expectancy of at least 3 months. - Negative pregnancy test (if female in reproductive years). - Adequate bone marrow, liver and kidney function: leukocyte > 3500/mm3; absolute neutrophil count (ANC) > 1500/mm3; platelet count > 100000/mm3; hemoglobin > 10 g/dl; creatinine < 1.5 mg/dL; total bilirubin = 1.5 x upper limit of normal range (ULN); SGOT e SGPT = 2.5 ULN - At the time of start of treatment, at least 2 weeks must have elapsed since completion of prior chemotherapy, minor surgery and radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated). - Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 4.03) grade = 1 for hematologic toxicities and = 2 for non hematologic toxicities, with the exception of alopecia. - Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol. Exclusion Criteria: - History of cardiac disease - Ongoing infection > Grade 2 according to NCI-CTCAE version 4.03. Hepatitis B is allowed if no active replication (defined as abnormal ALT >2xULN associated with HBV DNA >20,000 IU/mL) is present - Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection - History of interstitial lung disease (ILD). - Any cancer curatively treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1). - Renal failure requiring hemo- or peritoneal dialysis. - Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening - Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening. - History of organ allograft, cornea transplantation will be allowed - Active CNS metastases not controllable with radiotherapy or corticosteroids Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR. - Known history of hypersensitivity to study drugs - Non-healing wound, ulcer, or bone fracture. - Patients with seizure disorder requiring medication. - Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter). - Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. - Pregnant or lactating women. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of study treatment and a negative result must be documented before first dose of study drug. |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University Cancer Institute and Hospital | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) | the rate of complete response and partial response among all evaluable patients | 12month | |
Secondary | Disease control rate (DCR) | the rate of complete response, partial response and stable disease among all evaluable patients | 12 months | |
Secondary | Progression-free Survival (PFS) | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause. | 12 months | |
Secondary | Overall Survival (OS) | Duration from the date of initial treatment to the date of death due to any cause. | 24 months | |
Secondary | Adverse events (AE) | Adverse events in each cycle were documented based on CTCAE v 4.03 | 24 months |
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