Actively Recruiting
A Prospective, Single-arm, Phase II Study Assessing the Efficacy of Gemcitabine, Nab-paclitaxel, and Cadonilimab With Sequential Short-course Radiotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma Patients.
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-04
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring a treatment approach for patients with locally advanced pancreatic ductal adenocarcinoma, a severe form of pancreatic cancer. This phase II clinical study is designed to evaluate how well the combination of Gemcitabine, Nab-paclitaxel, and Cadonilimab with sequential short-course radiotherapy works for this condition. The study aims to assess both the effectiveness and safety of this combined treatment strategy in patients who have not received previous anti-tumor therapies. Participants will receive one cycle of Gemcitabine and Nab-paclitaxel combined with Cadonilimab, followed by a course of short-term radiotherapy. After this, the same combination of drugs will be administered again. If possible, patients may undergo surgery to evaluate the treatment's impact. The treatment plan includes a total of eight chemotherapy cycles, followed by maintenance therapy with Cadonilimab for up to one year. Throughout the study, participants will undergo regular assessments including imaging to measure tumor response based on standard criteria. Researchers will monitor clinical benefit rates, overall response, progression-free survival, and overall survival over one year. Safety will be closely observed by recording any adverse events. The total duration of participation may last up to one year, including treatment and follow-up periods to evaluate long-term outcomes.
CONDITIONS
Brief Title
AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any trial procedures
- Aged between 18 and 75 years
- Confirmed pancreatic cancer by histopathology
- Diagnosed with locally advanced pancreatic ductal adenocarcinoma
- No prior anti-tumor treatment including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- At least one measurable lesion on imaging based on RECIST 1.1
- ECOG performance status score of 0 or 1
- Expected survival time longer than 3 months
- Adequate organ function with specific blood counts and laboratory values within defined limits
- Negative pregnancy test for women of childbearing potential before treatment start
- Use of effective contraception during treatment and for specified periods after last dose
You will not qualify if you...
- Malignant diseases other than pancreatic cancer diagnosed within 5 years, except certain skin cancers
- Participation in another interventional clinical study or use of study medication/device within 4 weeks prior to treatment
- Prior therapy with immune checkpoint inhibitors or similar agents
- Recent use of systemic anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks
- Active autoimmune disease requiring systemic therapy within 2 years
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before treatment
- History of organ or stem cell transplantation (except corneal)
- Known allergy to study drugs or their components
- Incomplete recovery from prior treatment toxicities
- HIV infection
- Uncontrolled active hepatitis B or active hepatitis C infection
- Recent live vaccinations within 30 days
- Pregnancy or lactation
- Severe or uncontrolled systemic diseases including significant heart conditions, unstable angina, recent thrombosis events, poorly controlled blood pressure, lung diseases, active infections, liver diseases, poorly controlled diabetes, significant proteinuria, mental disorders or inability to cooperate
- Other medical conditions or risks deemed unsuitable by researchers
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 - Approximately 6 months (8 chemotherapy cycles)
Participants receive one cycle of Gemcitabine and Nab-paclitaxel combined with Cadonilimab, followed by sequential short-course radiotherapy, then continue receiving Gemcitabine and Nab-paclitaxel combined with Cadonilimab for a total of 8 chemotherapy cycles.
Multiple visits for chemotherapy and radiotherapy over 8 cycles
Duration - Variable depending on surgical scheduling
If feasible, participants undergo radical surgery to assess treatment efficacy.
1 surgical visit with possible pre- and post-operative assessments
Duration - Up to 1 year
Participants receive Cadonilimab maintenance treatment for up to 1 year following chemotherapy.
Regular visits for Cadonilimab infusions during maintenance
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
R
Rui Liu, MD
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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