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

NCT07392541 | Recruiting Phase 1

• 1 other identifier: CHALLENGE-07
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Biliary Tract Carcinoma

Keywords

Advanced Biliary Tract Carcinoma; adebrelimab; simvastatin

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 Outcomes (5)

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

• Disease Control Rate (DCR)

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

• Duration of Response (DOR)

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

• Incidence of Treatment-Related Adverse Events (TRAEs)

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

Study Arms (1)

Single Group Intervention

EXPERIMENTAL

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; Drug: Gemcitabine + Cisplatin; Drug: Simvastatin 20mg

Interventions

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.

Also known as: SHR-1316

Single Group Intervention

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).

Also known as: GemCis

Single Group Intervention

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.

Single Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Gemcitabine; Cisplatin; Simvastatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Wanguang Zhang, M.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Zeyang Ding, M.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang WU, M.D.

CONTACT

13636076910; 255001907@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)