Actively Recruiting
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-20
43
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
S
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX).
CONDITIONS
Official Title
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older, male or female
- Advanced biliary tract malignant tumor confirmed by histopathology or cytology
- No prior systemic therapy for biliary tract cancer
- Not suitable for surgery or has progressed after surgery/local treatment
- Completed local therapy at least 4 weeks before baseline imaging, with recovery of toxicity except alopecia to grade 1 or less
- At least one measurable lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Expected survival of at least 12 weeks
- Normal or acceptable blood, liver, kidney, heart, bone marrow functions per protocol-defined laboratory criteria
- Able to provide fresh or archived tumor tissue and pathology reports
- Fertile women must agree to contraception and be non-lactating with a negative pregnancy test
- Male patients with partners of reproductive age must agree to contraception and not donate sperm during study
You will not qualify if you...
- Active malignancies other than biliary tract cancer within the past 5 years, except certain cured localized tumors
- History of organ or allogeneic bone marrow transplantation
- Received investigational drug within 28 days before study treatment
- Moderate or severe symptomatic ascites, pleural or pericardial effusion
- Recent gastrointestinal bleeding or high bleeding risk within 6 months
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Known bleeding disorders or recent therapeutic anticoagulant use
- Recent use of high-dose aspirin or certain antiplatelet drugs within 10 days
- Thrombotic or embolic events within 6 months
- Uncontrolled or significant cardiac diseases or abnormal heart function
- Uncontrolled hypertension or recent hypertensive crisis
- Major vascular disease or recent major surgery within 4 weeks
- Unexplained intra-abdominal pneumatosis
- Central nervous system metastases or major airway/vessel involvement by tumor
- History of hepatic encephalopathy or active/interstitial lung disease affecting lung function
- Active or history of autoimmune disease with potential recurrence, except controlled cases
- Recent immunosuppressant or systemic hormone therapy within 14 days
- Severe allergy to monoclonal antibodies
- Severe infection or recent antibiotic treatment within 4 weeks
- Congenital or acquired immune deficiency
- Co-infection with hepatitis B and C
- Recent live attenuated vaccine use or expected need during treatment
- Other conditions affecting study safety or results as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guanzhou, Guangdong, China, 512000
Actively Recruiting
Research Team
W
Wenbin Li, archiater
CONTACT
J
Junkai Ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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