Advanced Cancer, Biliary Tract Cancer
Conditions
Keywords
Biliary Tract Cancer, Envafolimab, Simvastatin, Immunotherapy, Chemotherapy
Brief summary
Brief Summary The goal of this clinical trial is to test whether the combination of Envafolimab (an immunotherapy drug), chemotherapy (gemcitabine + cisplatin), and simvastatin can help treat advanced biliary tract cancer (BTC) that cannot be removed by surgery or has spread. The study will also evaluate the safety of this treatment combination. Key Questions Does the combination treatment help shrink tumors or slow cancer growth better than standard options? What side effects do participants experience with this treatment? What Will Participants Do? Receive Envafolimab (IV infusion) + gemcitabine/cisplatin (chemotherapy) + simvastatin (oral pill) every 3 weeks for up to 8 cycles (\ 6 months). After 8 cycles, continue with Envafolimab + simvastatin alone every 4 weeks until cancer worsens or side effects become too severe. Undergo regular scans, blood tests, and clinic visits to monitor tumor response and safety.
Interventions
DRUGEnvafolimab + Gemcitabine + Cisplatin + Simvastatin
Envafolimab (generic name): Dose: 300 mg, intravenous (IV) infusion. Schedule: Day 1 of each 21-day cycle (induction phase); every 28 days (maintenance phase). Role: PD-L1 inhibitor immunotherapy. Gemcitabine (generic name): Dose: 1,000 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only). Cisplatin (generic name): Dose: 25 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only). Simvastatin (generic name): Dose: 40 mg, oral tablet. Schedule: Daily (continuously through induction and maintenance phases). Investigational Role: Potential immunomodulator and chemosensitizer in biliary tract cancer. Treatment Phases: Induction Phase (Cycles 1-8, 21-day cycles): All four drugs administered. Maintenance Phase (Post-Cycle 8): Envafolimab + Simvastatin only (28-day cycles).
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age : ≥18 years old. * Diagnosis : Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer). * Prior Treatment :Treatment-naïve for unresectable/metastatic disease at initial diagnosis, OR Disease recurrence ≥6 months after curative surgery or adjuvant therapy. * Performance Status : ECOG PS 0 or 1. * Measurable Disease : At least one radiologically measurable lesion per RECIST 1.1 (tumor lesion ≥10 mm on CT scan, lymph node ≥15 mm in short axis). * Organ Function : No severe functional impairment of heart, lung, brain, or other vital organs.
Exclusion criteria
* Disease Type : Ampulla of Vater cancer. * Autoimmune Disease : Active or previously documented autoimmune/inflammatory disorders. * Allergy : Hypersensitivity to any study drug (Envafolimab, gemcitabine, cisplatin, or simvastatin). * Liver Function : Decompensated liver dysfunction. * Psychiatric History : Severe psychiatric disorders. * Recent Trials : Participation in other drug/device trials within 4 weeks prior to enrollment. * Compliance : Inability to adhere to protocol requirements or follow-up schedule. * Investigator's Discretion : Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) at 24 Weeks | From treatment initiation until 24 weeks (or disease progression, if earlier). | Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by CT/MRI scans after 24 weeks of treatment. CR: disappearance of all target lesions; PR: ≥30% decrease in target lesion diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 2 years. | Time from treatment start to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 2 years. | Time from treatment start to death from any cause. |
| Disease Control Rate (DCR) | Up to 2 years. | Proportion of participants with CR, PR, or stable disease (SD) lasting ≥12 weeks. |
| Duration of Response (DOR) | Up to 2 years. | Time from first documented response (CR/PR) to disease progression or death. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first dose until 30 days after last dose. | Frequency and severity of adverse events graded by CTCAE v5.0. |
Contacts
Primary ContactWanguang Prof. Zhang, M.D.
Outcome results
None listed