Actively Recruiting
Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-09-19
80
Participants Needed
7
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms
CONDITIONS
Official Title
Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged 18 to 75 years at consent
- Diagnosed with pancreatic ductal adenocarcinoma by histology or cytology
- At least one measurable metastatic lesion per RECIST 1.1
- No prior systemic anti-tumor therapy or progression >6 months after neoadjuvant/adjuvant therapy
- ECOG performance status 0-1 with expected survival >3 months
- Normal major organ function
- Use reliable contraception during study and for 6 months after; females must have negative pregnancy test within 7 days before enrollment and not be breastfeeding
You will not qualify if you...
- History or current diagnosis of other malignancies within 5 years
- Unresolved toxicities >Grade 1 from prior treatments except alopecia
- Major surgery, significant trauma, or unhealed wounds/fractures within 28 days before first dose
- Bleeding events ≥Grade 3 within 4 weeks before first dose
- Arterial or venous thrombosis within 6 months before first dose
- Active gastrointestinal ulcers, bleeding conditions, or persistent positive fecal occult blood within 6 months before first dose
- Unstable or untreated hepatitis B or C infections
- Substance abuse or psychiatric disorders
- Symptomatic interstitial lung disease or lung toxicity risks
- Severe or uncontrolled diseases
- Non-ductal pancreatic tumor types
- Tumors invading major blood vessels or gastrointestinal tract with high bleeding risk
- Known central nervous system metastases or carcinomatous meningitis
- Uncontrolled pleural, pericardial effusions, or ascites needing repeated drainage
- Severe allergic reactions to biologics or sensitivities to TQB2868 components
- Recent systemic corticosteroid or immunosuppressive treatment
- Recent live attenuated vaccine use
- Systemic therapy within 2 years before first dose
- Participation in other anti-tumor drug trials within 28 days before first dose
- Other conditions posing severe safety risks or preventing study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
2
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450039
Not Yet Recruiting
3
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
5
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
6
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
7
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
X
Xianjun Yu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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