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Biliary Tract NeoplasmsPhase 2NCT07109167

The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors

A Phase 2 study testing Benmelstobart combined with gemcitabine and cisplatin in people with Biliary Tract Neoplasms, run by The Second Affiliated Hospital of Shandong First Medical University.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Neoplasms
What is being tested?
Benmelstobart combined with gemcitabine and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 1 Aug 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic/extrahepatic cholangiocarcinoma, with at least one measurable lesion per RECIST v1.1 criteria. Tissue samples must be provided for biomarker analysis, preferably recently obtained tissue. If recent tissue is unavailable, 5-8 archived 5μm-thick paraffin-embedded sections are acceptable.
  • ECOG performance status: 0 or 1. Life expectancy ≥12 weeks.
  • Normal major organ function, defined as meeting the following criteria:
  • Hematological tests:
  • Hemoglobin (HB) ≥90 g/L (without blood transfusion within 14 days prior).
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L.
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  • Platelet count (PLT) ≥80×10⁹/L.
  • Biochemical tests:
  • Albumin (ALB) ≥30 g/L (without albumin transfusion within 14 days prior).
  • ALT and AST <2.5×upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤5×ULN.
  • Total bilirubin (TBIL) ≤1.5×ULN.
  • Plasma creatinine ≤1.5×ULN; or creatinine clearance (CCr) ≥60 ml/min. Subject voluntarily agrees to participate, signs the informed consent form, and is able to comply with scheduled study visits and procedures.
  • Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment completion.
  • Exclusion Criteria Confirmed allergy to any component of Benmelstobart Injection. Uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg), coronary heart disease of Grade I or higher, arrhythmia of Grade I or higher (including QTc interval prolongation: males >450 ms, females >470 ms), or heart failure of Grade I or higher; patients with positive urine protein.
  • Patients with definite gastrointestinal bleeding tendency, including: active local ulcerative lesions with fecal occult blood test (++); history of melena or hematemesis within 2 months.
  • Coagulopathy (INR >1.5, APTT >1.5×ULN) or bleeding tendency. Multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
  • Patients with central nervous system metastases. Pregnant or lactating women. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
  • Patients with a history of psychotropic drug abuse who are unable to abstain or with mental disorders.
  • Patients who participated in other drug clinical trials within 4 weeks. Patients with abnormal thyroid function. Urine protein ≥++ or 24-hour urine protein >1.0 g. Radiotherapy to target lesions within 4 weeks prior to the first dose of study treatment.
  • Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., ≤10 mg/day prednisone or equivalent dose of other glucocorticoids).
  • Administration of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planned during the study period.
  • Major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or unhealed wounds, ulcers, or fractures.
  • Active, known, or suspected autoimmune disease or history of such diseases within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy are eligible).
  • Uncontrolled concurrent diseases including but not limited to: HIV infection (HIV antibody positive); active or poorly controlled severe infections.
  • Symptomatic congestive heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias.
  • History of interstitial lung disease. Pregnant or lactating female patients. Known history of primary immunodeficiency. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

peng Jin contact

13165381171

kongyingcoco@163.com

About this study

Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.

Being tested
Benmelstobart combined with gemcitabine and 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.

  • Benmelstobart combined with gemcitabine and cisplatinDrug

    Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8

Study groups in NCT07109167
Study groupRoleWhat they receive
Benmelstobart combined with gemcitabine and cisplatinExperimentalBenmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8
Receives: Drug: Benmelstobart combined with gemcitabine and cisplatin

What is being measured

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

  1. Progression Free Survival

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    Measured: 2 years

Secondary outcomes (3)

  1. Outcome Measure

    Time from randomization to death from any cause

    Measured: 3 years

  2. Objective Response Rate

    It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)

    Measured: 2 years

  3. Quality of life score

    Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance

    Measured: 3 years

Timeline

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

  1. First posted7 Aug 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109167
Sponsor's protocol ID
MT-007
Status last verified
Jul 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Benmelstobart combined with gemcitabine and cisplatin in people with Biliary Tract Neoplasms, run by The Second Affiliated Hospital of Shandong First Medical University.

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 26 inclusion and 0 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 7 Aug 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 peng Jin (13165381171, kongyingcoco@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 2 years). 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 NCT07109167.

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 7 Aug 2025.

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