Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

• Status: Not yet recruiting
• Trial end date: 2025-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Criteria

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.