Actively Recruiting
Phase II Study of TQB2916 Injection Combined With Gemcitabine and Albumin-paclitaxel as First-line Treatment for Metastatic Pancreatic Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-05-08
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using TQB2916 injection with gemcitabine and albumin-paclitaxel as the first-line therapy for adults with metastatic pancreatic cancer. This study is a Phase II clinical trial designed to assess this new treatment approach in patients who have not received prior systemic anti-tumor therapy. The trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., and focuses on improving outcomes in this advanced cancer. The treatment involves giving TQB2916 injection combined with chemotherapy drugs, gemcitabine and albumin-paclitaxel, in 28-day cycles. Patients receive this combination as their initial therapy for metastatic pancreatic cancer. The study does not include a comparison or placebo group and uses an open-label design where both patients and researchers know the treatment being given. Participants will be monitored for up to 12 months to evaluate various outcomes including the rate of progression-free survival at 6 months, objective remission, disease control, event-free survival, overall survival, duration of response, adverse events, and immune response. Assessments will include clinical evaluations and safety monitoring throughout the study period. The goal is to gather comprehensive data on the treatment’s effects and safety profile during and after the treatment cycles.
CONDITIONS
Brief 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 the study and sign informed consent
- Age between 18 and 75 years at consent
- Confirmed pancreatic ductal adenocarcinoma by tissue or cytology
- At least one measurable lesion per RECIST 1.1 standard
- No prior systemic anti-tumor treatment
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Expected survival longer than 3 months
- Main organs functioning well
- Must use reliable contraception during the study and for 6 months after
- Negative serum pregnancy test within 7 days before enrollment
- Subjects must not be lactating
You will not qualify if you...
- History or presence of other malignant tumors within 5 years except certain cured cancers
- Unresolved toxic reactions above grade 1 (except alopecia) from prior treatments
- Major surgery, traumatic injury, or unhealed wounds/fractures within 28 days before treatment
- Bleeding events of grade 3 or higher within 4 weeks before treatment
- Recent thrombotic events within 6 months before treatment
- Hepatitis B or unstable Hepatitis C infection requiring antiviral treatment
- Active syphilis infection
- History of psychotropic drug abuse or uncontrolled mental disorders
- Symptomatic interstitial lung disease or related pulmonary conditions
- 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 needing repeated drainage
- Severe allergy to large molecule drugs or TQB2916 components
- Use of systemic hormones or immunosuppressants above specified doses within 28 days before treatment
- Recent live vaccine within 28 days before treatment or planned during study
- Active autoimmune disease requiring systemic treatment within 2 years
- Participation in other anti-tumor drug trials within 28 days before treatment
- Any conditions judged by the researcher to endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive TQB2916 injection combined with chemotherapy drugs gemcitabine and albumin-paclitaxel as first-line treatment for metastatic pancreatic cancer in repeated 28-day cycles.
Visits every 28 days for treatment cycles
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here