Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma
Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study
Beijing Tsinghua Chang Gung Hospital
66 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
Summary
Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.
Eligibility
Inclusion Criteria8
- Age ≥ 18 years, male or female
- Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery
- At least one measurable lesion according RECIST v1.1 criteria \[spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\]
- Life expectancy ≥ 3 months
- The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10\^9/L; platelets ≥ 125 × 10\^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF \> 50%
- The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia)
- Female patients of childbearing potential (including early menopause, menopause \< 2 years, and non-surgical sterilization), male patients and their partners must agree to use effective contraceptive measures during the study
- Patients or their legal representatives can understand and offer informed consent, being willing to take part in the follow-up with good compliance
Exclusion Criteria9
- Pregnant or lactating women, men or women who are reluctant to take effective contraceptive measures
- Previous treatment with oncolytic viruses (such as T-VEC)
- Abnormal coagulation function, or having a bleeding tendency, or receiving thrombolytic or anticoagulant therapy
- Patients with poor glycemic control
- Known central nervous system tumors, including metastatic brain tumors
- Accompanied by any unstable systemic diseases, including but not limited to severe infection, resistant hypertension, unstable angina, stroke or myocardial infarction within 6 months, congestive heart failure, and serious cardiac arrhythmia requiring medication, renal or metabolic disease requiring medication
- Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium, fluorouracil
- History of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy within 7 days before enrollment, or any form of immunosuppressive therapy
- Other conditions that are not suitable for participating in this trial
Interventions
H101 will be intratumorally injected 3 days before HAIC. Dosage of H101: 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm.
Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium. The infusion will be continued for 2-3 days according to patients' tolerance and tumor conditions. The standard treatment for HAIC consists of 4-6 cycles, with the second cycle being 3 weeks after the end of the first HAIC cycle and the subsequent cycles being 4 weeks after the end of the previous HAIC.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05124002