Adebrelimab plus gemcitabine, cisplatin, and simvastatin for advanced biliary tract cancer
A Single-Arm, Multicenter, Exploratory Clinical Study of Adebrelimab in Combination With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Patients With Locally Advanced or Metastatic Biliary Tract Malignancies
This trial tests whether adding adebrelimab and simvastatin to standard gemcitabine–cisplatin chemotherapy helps people with advanced biliary tract cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | adebrelimab, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07392541 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 interventional trial gives all participants a four-drug combination of adebrelimab, gemcitabine, cisplatin, and simvastatin. Phase 1 focuses on safety, tolerability, and dosing while phase 2 collects preliminary evidence of tumor response and disease control. Investigators will monitor tumor size by RECIST 1.1, record adverse events, and track progression-free and overall survival. The study is exploratory and aims to gather initial data on whether adding an investigational immunotherapy and a statin to standard chemotherapy is a promising approach for advanced biliary tract cancer.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma, ECOG 0–1, at least one measurable lesion, and no prior systemic therapy for advanced disease (or recurrence >6 months after adjuvant therapy) are ideal candidates.
Not a fit: Patients with ampullary carcinoma, active autoimmune or inflammatory disorders, severe organ dysfunction, known hypersensitivity to the study drugs, or ECOG performance status >1 are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination could produce greater tumor shrinkage and longer progression-free survival than chemotherapy alone.
How similar studies have performed: Adding immune checkpoint inhibitors to gemcitabine–cisplatin has shown benefit in advanced biliary tract cancer in other trials (for example durvalumab combinations), while the specific addition of simvastatin remains more novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer). * No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months after radical surgery or adjuvant therapy is allowed. * ECOG Performance Status of 0 or 1. * At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm). * No severe dysfunction of major organs (heart, lungs, brain, etc.). Exclusion Criteria: * Diagnosis of ampullary carcinoma. * Presence of active or previously documented autoimmune or inflammatory disorders. * Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin). * Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin \> 1.5 times the upper limit of normal (ULN), AND/OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times ULN. * Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment. * Inability to comply with the study protocol for treatment or scheduled follow-up assessments. * Any other condition deemed by the investigator as unsuitable for participation in the study.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Wanguang Zhang, M.D. — Tongji Hospital
- Study coordinator: Yang WU, M.D.
- Email: 255001907@qq.com
- Phone: 13636076910
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.