Actively Recruiting
Multi-cohort, Open Phase II Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy for First-line Treatment of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a combination treatment including TQB2868 injection, anlotinib capsules, and chemotherapy in patients with metastatic pancreatic neoplasms. This phase II clinical study focuses on patients newly diagnosed with pancreatic ductal adenocarcinoma who have not received prior systemic anti-tumor therapy, aiming to assess this combined approach as a first-line treatment option. The treatment involves two study groups: one receiving TQB2868 injection combined with gemcitabine and albumin paclitaxel injections plus oral anlotinib capsules, and the other receiving TQB2868 injection combined with gemcitabine and albumin paclitaxel injections without anlotinib. Treatments are given in cycles of 28 days during the initial treatment period, followed by a maintenance period with cycles of 21 days, while anlotinib is taken orally once daily for two weeks followed by a one-week break. Participants will be monitored regularly through evaluations every eight weeks to measure progression-free survival and other outcomes such as response rate, overall survival, and adverse events. Blood samples will be collected at specified times to analyze drug concentration and immune response. The study includes safety assessments throughout and plans to continue until November 2026, with detailed pharmacokinetic and immunogenicity testing during treatment cycles.
CONDITIONS
Brief 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...
- Volunteers must sign informed consent.
- Age between 18 and 75 years at consent.
- Diagnosis of pancreatic ductal adenocarcinoma confirmed by histology or cytology.
- At least one metastatic lesion evaluable by RECIST 1.1.
- No prior systemic anti-tumor therapy, or progression more than 6 months after neoadjuvant or adjuvant therapy.
- ECOG performance status 0-1 with expected survival over 3 months.
- Normal major organ function.
- Use of reliable contraception during and for 6 months after study; females must have a negative pregnancy test and not be breastfeeding.
You will not qualify if you...
- History or current diagnosis of other cancers within 5 years.
- Unresolved toxicities from prior treatments above Grade 1 except alopecia.
- Major surgery, severe injuries, or unhealed wounds/fractures within 28 days before first dose.
- Severe bleeding events within 4 weeks before first dose.
- Arterial or venous thrombosis within 6 months before first dose.
- Active gastrointestinal ulcers or bleeding conditions within 6 months.
- Unstable or untreated hepatitis B or C infection.
- Substance abuse or psychiatric disorders preventing participation.
- Symptomatic lung disease or risk of lung toxicity.
- Severe or uncontrolled medical conditions.
- Other pathological tumor types such as acinar cell carcinoma.
- Tumors invading major blood vessels or gastrointestinal tract with high bleeding risk.
- Known brain metastases or carcinomatous meningitis.
- Uncontrolled pleural, pericardial effusion, or ascites.
- Severe allergic reactions to biologics or TQB2868 components.
- Recent or ongoing corticosteroid or immunosuppressive therapy.
- Recent live attenuated vaccines or planned during study.
- Recent systemic therapy for other conditions within 2 years.
- Participation in other anti-tumor drug trials within 28 days.
- Any condition deemed unsafe or unsuitable by investigators.
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 TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, with or without Anlotinib capsules, in 28-day treatment cycles. Anlotinib capsules are taken orally once a day for 2 weeks followed by a 1 week untreated recovery phase. Treatment cycles continue as per protocol.
Efficacy evaluations every 8 weeks; frequent dosing visits as per treatment cycles
Duration - Maintenance cycles of 21 days continued as per protocol
Participants continue with maintenance therapy of TQB2868 injection combined with Gemcitabine injection, with or without Anlotinib capsules, in 21-day treatment cycles. Anlotinib capsules are taken orally once a day for 2 weeks followed by a 1 week untreated recovery phase.
Efficacy evaluations every 8 weeks; dosing visits according to maintenance cycles
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
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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