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

NCT07109167 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MT-007
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (3)

• Outcome Measure

  3 years

• Objective Response Rate

  2 years

• Quality of life score

  3 years

Study Arms (1)

Benmelstobart combined with gemcitabine and cisplatin

EXPERIMENTAL

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

Drug: Benmelstobart combined with gemcitabine and cisplatin

Interventions

Benmelstobart combined with gemcitabine and cisplatin DRUG

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

Benmelstobart combined with gemcitabine and cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• yan hai Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

peng Jin

CONTACT

13165381171; kongyingcoco@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share