Using a virus and chemotherapy to treat liver cancer
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
This study is testing if a combination of a special virus and chemotherapy can help people with liver cancer that can't be surgically removed live longer without their cancer getting worse.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05124002 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of combining recombinant human adenovirus type 5 with hepatic arterial infusion chemotherapy (HAIC) using FOLFOX for patients with unresectable intrahepatic mass-forming cholangiocarcinoma. The study is designed as a single-arm trial with a total of 66 participants, aiming to improve the progression-free survival (PFS) rate compared to conventional HAIC. Participants will be monitored for their response to treatment and any adverse effects, with the goal of achieving a one-year PFS rate of 60%. The trial employs Simon's two-stage design to ensure robust statistical analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable intrahepatic mass-forming cholangiocarcinoma who have at least one measurable lesion.
Not a fit: Patients with resectable tumors or those who have not recovered from previous anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced liver cancer.
How similar studies have performed: Previous studies have shown promising results with oncolytic viruses in cancer treatment, indicating potential for success with this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Beijing, Beijing
- Beijing Tsinghua Chang Gung Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zhang Yuewei, Md — Beijing Tsinghua Chang Gung Hospital
- Study coordinator: Wang Tianxiao, MD
- Email: wtx419@163.com
- Phone: 0086-13969193950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.