AzTrials
AzTrials

Biliary Tract NeoplasmsPhase 2NCT04910386

Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers

A Phase 2 study testing Envafolimab plus Gemcitabine&Cisplatin and Gemcitabine&Cisplatin in people with Biliary Tract Neoplasms, run by 3D Medicines (Sichuan) Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Neoplasms
What is being tested?
Envafolimab plus Gemcitabine&Cisplatin and Gemcitabine&Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
No sites listed yet
Study dates
1 Jun 2027to Dec 2029
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

  • Be ≥ 18 years of age;
  • Subjects must have a histopathological or cytological diagnosis of locally advanced or metastatic gallbladder cancer (GBC) or cholangiocarcinoma (CCA);
  • Subjects who have not received prior systemic therapy for advanced disease or who have received adjuvant or neoadjuvant chemotherapy in one regimen and relapsed > 6 months after the end of chemotherapy can be enrolled;
  • Child-Pugh liver function rating: class A (5-6 points) and better class B (7 points) (see Appendix 3);
  • ECOG PS score 0 or 1 (see Appendix 1);
  • Expected survival ≥ 12 weeks;
Show all 10Show fewer
  • Subjects with at least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);
  • Subject must have adequate major organ and bone marrow functions (no blood transfusion and no use of hematopoietic growth factor within 14 days before the first dose of study treatment):
  • 1) Hematology: neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, and hemoglobin ≥ 90 g/L; 2) International normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 3) Liver function: serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN; Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤ 2.5 × ULN OR ≤ 5 × ULN for subjects with liver metastases; 4) Renal function: serum creatinine ≤ 1.5 x ULN and creatinine clearance (CCr) > 60 mL/min (assessed with Cockcroft-Gault formula, see Appendix 6); 5) Normal cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.
  • 9. Subjects must fully understand the study, voluntarily participate, and sign the informed consent form (ICF).

Who cannot join

  • Has participated in another clinical trials of other investigational drugs or investigational devices within 4 weeks prior to the first dose of investigational product treatment (palliative radiotherapy for bone metastases completed at least 2 weeks prior to investigational product treatment is allowed);
  • The investigator assesses liver metastases as 50% or more of the total liver volume;
  • Has ascites requiring drainage or treatment with diuretics, or pleural or pericardial effusion requiring drainage and/or associated with symptoms of tachypnea within 4 weeks prior to the first dose of investigational product treatment;
  • Has biliary obstruction with clinical intervention that has not resolved or requires anti-infective therapy as judged by the investigator 14 days prior to the first dose of investigational product treatment;
  • Has prior liver transplantation;
  • Has known active brain metastases or spinal cord compression; subjects with previously treated brain metastases may be enrolled if their clinical condition is stable and radiographic evidence shows no disease progression within 4 weeks prior to the first dose of investigational product treatment, and corticosteroid therapy is not required within 4 weeks prior to the first dose of investigational product treatment;
Show all 21Show fewer
  • Has a known additional malignant tumor in the past 5 years (except for skin basal cell or squamous cell carcinoma, or cervical, breast and other carcinoma in situ after radical surgery);
  • Has received major surgical procedures (except biopsy) or incomplete healing of surgical wound within 4 weeks prior to the first dose of investigational product treatment;
  • Has any unresolved toxicity (CTCAE Grade ≥ 2) from prior anti-tumor therapy, except for alopecia or Grade 2 peripheral neuropathy or other laboratory abnormalities that are not clinically significant as assessed by the investigator;
  • Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism that is stable on hormone replacement will not be excluded from the study;
  • Has known history of HIV, or active bacterial or fungal infection requiring systemic treatment within 14 days prior to the first dose of investigational product treatment;
  • Has history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease or presence of active pneumonitis on chest CT scan within 4 weeks before the first dose of investigational product treatment;
  • Has active hepatitis B (HBsAg positive and HBV-DNA ≥ 104 copies/mL) or hepatitis C (HCV antibody positive and HCV-RNA quantitative test results greater than the lower limit of detection);
  • Has a history or current evidence of clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, acute ischemic/hemorrhagic stroke, congestive heart failure (≥ New York Heart Association Class II, see Appendix 4) within 6 months prior to enrollment; arrhythmias requiring treatment with other antiarrhythmic drugs in addition to β-blockers or digoxin; repeat QTcF interval > 450 milliseconds (ms) on ECG (see Appendix 5); hypertension not well controlled with antihypertensive drug therapy (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg);
  • Be receiving therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg/day is allowed); or receiving antiplatelet anticoagulant therapy (aspirin doses ≤ 300 mg/day and clopidogrel doses ≤ 75 mg/day are allowed);
  • Has received immunosuppressive drugs within 4 weeks prior to the first dose of investigational product treatment, excluding topical corticosteroids or systemic prednisone ≤ 10 mg/day or equivalent doses of other corticosteroids;
  • Has received live vaccines within 4 weeks before the first dose of investigational product treatment or plan to receive it during the study;
  • Has history of severe allergic reactions to chimeric or human antibodies or fusion proteins, or known allergies to biological products produced with Chinese hamster ovary cells or any component of envafolimab; known or suspected allergy to the chemotherapeutic drug gemcitabine/cisplatin and its components;
  • Be pregnant or breastfeeding;
  • Be childbearing potential but unwilling to accept effective contraceptive measures;
  • Any other disease, metabolic disorder or laboratory abnormalities, that the investigator considers that the subject is not suitable for the investigational product treatment, or will affect the interpretation of the study results, or put the subject at high risk.

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Being tested
Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin
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 plus Gemcitabine&CisplatinDrug

    Envafolimab a programmed death ligand immune check inhibitor Per Investigator decision

  • Gemcitabine&CisplatinDrug

    The standard of care for the patients with unresectable/metastatic biliary tract cancer

Study groups in NCT04910386
Study groupRoleWhat they receive
EnvafolimbExperimentalEnvafolimab plus Gemcitabine\&Cisplatin Envafolimab: 300 mg on Day 1 of each cycle, subcutaneous injection. Every 21 days is a treatment cycle. Gemcitabine (GEM): 1000 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles. Cisplatin (CIS): 25 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.
Receives: Drug: Envafolimab plus Gemcitabine&Cisplatin
Gemcitabine&CisplatinActive comparatorGemcitabine (GEM): 1000 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles. Cisplatin (CIS): 25 mg/m2 body surface area (BSA) administered on Days 1 and 8 of each cycle. Every 21 days is a treatment cycle with a maximum of 8 cycles.
Receives: Drug: Gemcitabine&Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To evaluate the progression-free survival (PFS) of envafolimab in combination with gemcitabine plus cisplatin (GemCis) versus first-line treatment of GemCis in patients with advanced biliary tract cancers (BTC).

    Measured: Observed by 12 weeks

Secondary outcomes (4)

  1. Overall survival (OS)

    To evaluate the overall survival (OS) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

    Measured: Observed by 12 weeks after progressive disease or end of treatment

  2. Objective response rate(ORR)

    To evaluate the objective response rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

    Measured: Observed by 12 weeks

  3. Duration of response (DoR)

    To evaluate the duration of response (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

    Measured: Observed by 12 weeks

  4. Disease control rate (DCR)

    To evaluate the disease control rate (assessed by the investigator per RECIST 1.1 criteria) of envafolimab in combination with GemCis versus GemCis in patients with advanced BTC;

    Measured: Observed by 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2021
  2. Study start1 Jun 2027 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04910386
Sponsor's protocol ID
KN035-US-002
Status last verified
Mar 2026
First submitted
27 May 2021
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab plus Gemcitabine&Cisplatin and Gemcitabine&Cisplatin in people with Biliary Tract Neoplasms, run by 3D Medicines (Sichuan) Co., Ltd..

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 10 inclusion and 21 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 25 Mar 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Observed by 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04910386.

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 25 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in