Actively Recruiting
A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-05-08
50
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial was a single-arm, open-label design to evaluate the efficacy and safety of "TQB2916+ gemcitabine + albumin-paclitaxel" as the first-line treatment for metastatic pancreatic cancer.
CONDITIONS
Official Title
A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily join and sign informed consent
- Age between 18 and 75 years at consent
- Pancreatic ductal adenocarcinoma confirmed by tissue or cytology
- At least one measurable lesion per RECIST 1.1
- No prior systemic anti-tumor treatment
- ECOG score 0-1 with expected survival over 3 months
- Adequate main organ function
- Use reliable contraception during and up to 6 months after study; negative serum pregnancy test within 7 days before enrollment; non-lactating
You will not qualify if you...
- History of other malignant tumors within 5 years except certain cured cancers
- Unresolved toxic reactions above CTCAE grade 1 from prior treatments (except alopecia)
- Major surgery, traumatic injury, or unhealed wounds/fractures within 28 days before first dose
- Bleeding events CTCAE grade 3 or higher within 4 weeks before first dose
- Hyperarterial/venous thrombotic events within 6 months before first dose
- Unstable hepatitis B or hepatitis C virus infection requiring antiviral treatment
- Active syphilis infection
- History of psychotropic drug abuse or mental disorders
- Symptomatic interstitial lung disease or conditions causing lung toxicity
- Severe or uncontrolled diseases
- Tumor invading important blood vessels with high bleeding risk
- Known central nervous system metastases or cancerous meningitis
- Uncontrolled pleural, pericardial effusion or ascites requiring repeated drainage
- Severe allergy to large molecule drugs or TQB2916 components
- Recent chronic systemic hormone or immunosuppressant use within 28 days
- Attenuated live vaccine within 28 days before study or planned during study
- Active autoimmune disease requiring systemic treatment within 2 years
- Participation in other anti-tumor drug trials within 28 days before study
- Other conditions judged by researchers as unsafe or unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yi Ba, Doctor
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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