Combining GEMOX with targeted therapy and immunotherapy for advanced cholangiocarcinoma
Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
This study is testing a new treatment that combines chemotherapy with targeted therapy and immunotherapy to see if it helps people with advanced bile duct cancer who haven't had other treatments yet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05215665 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of the GEMOX regimen combined with targeted therapy and immunotherapy in patients with advanced cholangiocarcinoma. The study aims to identify potential biomarkers while treating patients who have not received prior systemic or local treatment for their tumors. Participants will be monitored for their response to the treatment and overall health outcomes. The trial is designed for patients with locally advanced or metastatic disease, ensuring they have measurable lesions.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 70 with advanced cholangiocarcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with other malignant tumors in the past five years or those who have received prior immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced cholangiocarcinoma.
How similar studies have performed: While there have been studies exploring combinations of chemotherapy and immunotherapy, this specific combination for advanced cholangiocarcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, 18 years old ≤ age ≤ 70 years old * ECOG PS scores 0-1 * Expected survival time \> 12 weeks * Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria) * Not received any previous systemic or local treatment for the tumor * Sufficient organ and bone marrow function Exclusion Criteria: * Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ) * Ampullary tumor * Received treatment from other clinical trials within 4 weeks before the first dose * Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy * Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction * Uncontrollable pleural effusion, pericardial effusion or ascites * Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment * Allergic reactions to the drugs used in this study * HIV antibody positive, active hepatitis B or C (HBV, HCV) * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * other conditions that the investigator deems inappropriate for enrollment
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wei Liu, MD
- Email: mail4luwei@163.com
- Phone: +86 22-27468682
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.