Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Trial Title: Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

NCT ID: NCT05535647

Condition: Intrahepatic Cholangiocarcinoma

Conditions: Official terms:
Cholangiocarcinoma

Conditions: Keywords:
Intrahepatic Cholangiocarcinoma
Regorafenib
HAIC
FOLFOX

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Regorafenib and HAIC
Description: Regorafenib: oral 80mg/day, D1-21, Q28d; HAIC with FOLFOX: hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.
Arm group label: Regorafenib and HAIC

Intervention type: Drug
Intervention name: FOLFOX
Description: Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.
Arm group label: FOLFOX

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.

Detailed description: Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). However,only less than 25% of patients are resectable at diagnosis and, even in this subset of patients, relapse rate is high. Cisplatin and gemcitabine combination was identified as the standard first-line chemotherapy, yielding a median progression free survival (PFS) and median OS of 8.5 and 11.7 months, respectively. FOLFOX was the standard second-line chemotherapy. But the benefit of FOLFOX was limited.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University Cancer Institute and Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Start date: September 25, 2022

Completion date: September 25, 2025

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05535647