Combination treatment for large unresectable intrahepatic cholangiocarcinoma
Hepatic Arterial Infusion of GEMOX Plus Systemic Gemcitabine Chemotherapy Combined With Lenvatinib and PD-1 Inhibitor in Large Unresectable Intrahepatic Cholangiocarcinoma
This study is testing a new combination of treatments for adults with large, inoperable bile duct cancer to see if it helps them live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | lenvatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangzhou) |
| Trial ID | NCT06505486 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a combination treatment involving hepatic arterial infusion chemotherapy with gemcitabine and oxaliplatin, systemic gemcitabine chemotherapy, lenvatinib, and a PD-1 inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma. Patients aged 18-70 with specific health criteria and tumor characteristics were enrolled, and clinical data were collected retrospectively to assess tumor response, progression-free survival, overall survival, and adverse events. The primary endpoint of the study is overall survival, while progression-free survival serves as a secondary endpoint.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with unresectable intrahepatic cholangiocarcinoma larger than 5 cm and adequate organ function.
Not a fit: Patients with resectable tumors or those with significant comorbidities affecting organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with large unresectable intrahepatic cholangiocarcinoma.
How similar studies have performed: While this approach combines established treatments, the specific combination has not been widely tested, making it a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (a) age of 18-70 years; (b) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; (c) diagnosis of ICC by histopathological examination of tissue biopsy specimens; (d) unresectable ICC confirmed by a multidisciplinary staff including at least one experienced liver surgeon; (e) tumor size larger than 5 cm in maximum diameter; (f) adequate liver function (total bilirubin \< 3 times the upper limit of normal and aspartate/alanine transaminases \< 5 times the upper limit of normal), adequate renal function (serum creatinine concentration of no more than 1.5 times the upper limit of the normal level), adequate bone marrow function (white blood cell count\>3,000/mm3, hemoglobin\>9.0g/dl and platelet count \>100,000/mm3 ) and adequate coagulation function (prothrombin activity \> 40% and international normalized ratio (INR) \< 1.26); (g) patients received at least two cycles of GEMOX-HAIC + GEM-SYS combined with lenvatinib and PD-1 inhibitor; (h) patients with regular clinical data for evaluating the clinical efficacy and safety. Exclusion Criteria: (a) combined with other malignancies; (b) patients underwent any other chemotherapy regimens before, including gemcitabine and oxaliplatin; (c) patients received previous surgical resection or any other interventional procedures besides HAIC, such as transarterial chemoembolization (TACE), 125I seed implantation, radiofrequency ablation, microwave ablation, cryoablation, or percutaneous ethanol injection, etc.; (d) drug (chemotherapy drugs, lenvatinib, or PD-1 inhibitors) allergy; (e) patients with a history of autoimmune diseases; (f) patients with gastrointestinal bleeding of any grade within 4 weeks prior to the integrated treatment; (g) patients with uncontrolled comorbidities (e.g. general infection, serious dysfunction of heart or kidney, acute hepatitis or pneumonia, chronic obstructive pulmonary disease, or recent stroke).
Where this trial is running
Guangzhou, Guangzhou
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Jia-yan Ni, M.D. — Sun Yat-sem Memorial Hospital, Sun Yat-sen University
- Study coordinator: Jia-yan Ni, M.D.
- Email: nijaiyan3@mail.sysu.edu.cn
- Phone: 13660140273
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.