Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07392541

Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer

This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin.

All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Biliary Tract Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tongji Hospital

Wuhan, Hubei, China

Location status: Recruiting

Location contact

Wanguang Zhang, M.D.

PRINCIPAL_INVESTIGATOR

Yang WU, M.D.

CONTACT

[email protected]

13636076910

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adebrelimab

Drug

Adebrelimab is an anti-PD-L1 monoclonal antibody. During the initial combination phase (up to 8 cycles), it is administered intravenously at 1200 mg on Day 1 of each 21-day cycle. During the subsequent maintenance phase, it is administered at 1200 mg intravenously every 4 weeks.

Other names: SHR-1316

Gemcitabine + Cisplatin

Drug

Standard gemcitabine and cisplatin chemotherapy regimen. This combination is administered intravenously only during the initial treatment phase for a maximum of 8 cycles (21-day cycles).

Other names: GemCis

Simvastatin 20mg

Drug

Simvastatin is an HMG-CoA reductase inhibitor (statin). It is administered orally at a dose of 20 mg once daily continuously throughout both the initial combination phase and the subsequent maintenance phase until treatment completion criteria are met.

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From enrollment until the first documented disease progression or completion of study treatment, whichever occurs first, assessed up to approximately 2 years.

    The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor assessments will be performed by investigators via contrast-enhanced CT or MRI scans.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From enrollment until the first documented progression or death from any cause, assessed up to approximately 2 years

    PFS is defined as the time from the start of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.

  2. Overall Survival (OS)

    Time frame: From enrollment until death from any cause, assessed up to approximately 3 years.

    OS is defined as the time from the start of study treatment to death from any cause.

  3. Disease Control Rate (DCR)

    Time frame: From enrollment until the first documented disease progression or completion of study treatment, assessed up to approximately 2 years.

    DCR is defined as the proportion of participants achieving a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (lasting for at least 6 weeks) according to RECIST 1.1.

  4. Duration of Response (DOR)

    Time frame: From the first documented response until disease progression or death, assessed up to approximately 2 years.

    DOR is defined as the time from the first documentation of objective response (CR or PR) to the first documented disease progression or death from any cause, whichever occurs first, in participants who achieve a confirmed response.

  5. Incidence of Treatment-Related Adverse Events (TRAEs)

    Time frame: From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 2 years.

    The proportion of participants experiencing any adverse event determined by the investigator to be related to the study treatment regimen. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang WU, M.D.

CONTACT

[email protected]

13636076910

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.