Biliary Tract CancerPhase 2NCT07003815
Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
A Phase 2 study testing Envafolimab + Gemcitabine + Cisplatin + Simvastatin in people with Biliary Tract Cancer and Advanced Cancer, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Advanced Cancer
- What is being tested?
- Envafolimab + Gemcitabine + Cisplatin + Simvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients
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.
Read more
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.
- Conditions
- Biliary Tract Cancer, Advanced Cancer
- Being tested
- Envafolimab + Gemcitabine + Cisplatin + Simvastatin
- Keywords
- Biliary Tract Cancer, Envafolimab, Simvastatin, Immunotherapy, Chemotherapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab + Gemcitabine + Cisplatin + SimvastatinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy | Experimental | Intervention(s):
All enrolled participants will receive the following combination therapy:
Envafolimab (300 mg, intravenous infusion, Day 1 of each 21-day cycle) - a PD-L1 inhibitor immunotherapy.
Gemcitabine (1,000 mg/m², IV, Days 1 and 8 of each cycle) + Cisplatin (25 mg/m², IV, Days 1 and 8 of each cycle) - standard chemotherapy regimen.
Simvastatin (40 mg, oral daily) - repurposed as a potential synergistic agent.
Treatment Schedule:
Initial Phase (Cycles 1-8):
21-day cycles for up to 8 cycles (≈6 months). Drugs administered as above.
Maintenance Phase (Post-Cycle 8):
Continue Envafolimab (300 mg, IV, every 28 days) + Simvastatin (40 mg, oral daily) until disease progression or unacceptable toxicity. Receives: Drug: Envafolimab + Gemcitabine + Cisplatin + Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) at 24 Weeks
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.
Measured: From treatment initiation until 24 weeks (or disease progression, if earlier).
Secondary outcomes (5)
Progression-Free Survival (PFS)
Time from treatment start to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: Up to 2 years.
Overall Survival (OS)
Time from treatment start to death from any cause.
Measured: Up to 2 years.
Disease Control Rate (DCR)
Proportion of participants with CR, PR, or stable disease (SD) lasting ≥12 weeks.
Measured: Up to 2 years.
Duration of Response (DOR)
Time from first documented response (CR/PR) to disease progression or death.
Measured: Up to 2 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Frequency and severity of adverse events graded by CTCAE v5.0.
Measured: From first dose until 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003815
- Sponsor's protocol ID
- TJ-IRB202401114
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients
- ClinicalTrials.gov ID
- NCT07003815
- Acronym / sponsor ID
- TJ-IRB202401114
- Conditions
- Biliary Tract Cancer, Advanced Cancer
- Keywords
- Biliary Tract Cancer, Envafolimab, Simvastatin, Immunotherapy, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy | Experimental | Drug: Envafolimab + Gemcitabine + Cisplatin + SimvastatinIntervention(s): All enrolled participants will receive the following combination therapy: Envafolimab (300 mg, intravenous infusion, Day 1 of each 21-day cycle) - a PD-L1 inhibitor immunotherapy. Gemcitabine (1,000 mg/m², IV, Days 1 and 8 of each cycle) + Cisplatin (25 mg/m², IV, Days 1 and 8 of each cycle) - standard chemotherapy regimen. Simvastatin (40 mg, oral daily) - repurposed as a potential synergistic agent. Treatment Schedule: Initial Phase (Cycles 1-8): 21-day cycles for up to 8 cycles (≈6 months). Drugs administered as above. Maintenance Phase (Post-Cycle 8): Continue Envafolimab (300 mg, IV, every 28 days) + Simvastatin (40 mg, oral daily) until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envafolimab + Gemcitabine + Cisplatin + SimvastatinEnvafolimab (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). | Drug | Envafolimab + Gemcitabine/Cisplatin + Simvastatin Combination Therapy |
Primary outcome
Objective Response Rate (ORR) at 24 Weeks
Time frame: 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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 2 years.
Overall Survival (OS)
Time frame: Up to 2 years.
Disease Control Rate (DCR)
Time frame: Up to 2 years.
Duration of Response (DOR)
Time frame: Up to 2 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose until 30 days after last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab + Gemcitabine + Cisplatin + Simvastatin in people with Biliary Tract Cancer and Advanced Cancer, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanguang Prof. Zhang, M.D. (+8613636076910, wgzhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) at 24 Weeks (time frame: From treatment initiation until 24 weeks (or disease progression, if earlier).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.