Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age ≥18 years and age ≤75 years.
• ECOG score 0-1.
• Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
• Adequate bone marrow and organ function:
• Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
• Signed informed consent.
• Ability to comply with the study protocol and follow-up.
Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
zhong Wu, MD
wuzhong5555@126.com
028-85422851
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 43
Treatments
Experimental: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110)
Related Therapeutic Areas
Sponsors
Leads: Sichuan University