Adebrelimab plus gemcitabine, cisplatin, and simvastatin for advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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  Recruiting Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Jinan, Shandong · NCT07798947

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

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• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.