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

March 20, 2026 updated by: Wan-Guang Zhang, Tongji Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Principal Investigator:
          • Wanguang Zhang, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Intervention
All participants receive the combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day/cycle), followed by maintenance therapy with adebrelimab and simvastatin until disease progression or unacceptable toxicity.
Drug: Adebrelimab
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
Drug: Gemcitabine + Cisplatin
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
Drug: Simvastatin 20mg
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment until the first documented progression or death from any cause, assessed up to approximately 2 years
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.
From enrollment until death from any cause, assessed up to approximately 3 years.
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.
From enrollment until the first documented disease progression or completion of study treatment, assessed up to approximately 2 years.
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.
From the first documented response until disease progression or death, assessed up to approximately 2 years.
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.
From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Wanguang Zhang, M.D., Tongji Hospital
  • Principal Investigator: Zeyang Ding, M.D., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHALLENGE-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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