Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJinling Hospital, China
About this trial
Clinical Study on the Safety and Efficacy of the efficacy and safety of Adebrelimab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years old, gender unlimited;
Patients with resectable pancreatic adenocarcinoma confirmed by histopathology or cytology (CA19-9 > 150 U/ml);
No previous systemic treatment for pancreatic cancer;
Measurable lesions defined by RECIST standard v1.1 (according to Recist 1.1 standard, the CT scan diameter of tumor lesions is ≥10 mm, and the scan layer thickness is not more than 5 mm);
Disqualifiers
Concurrent with other uncured malignant tumors;
Subjects who have previously used PD-1/PD-L1 antibodies;
Subjects who can be surgically resected or treated with radical radiation;
Subjects with a history of bleeding and any bleeding event with a severity rating of 3 or above on CTCAE4.0 within 4 weeks prior to screening;
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab
Drug1200mg，i.v. , q3w
albumin-bound paclitaxel
Drug125 mg/m2, i.v.,d1,d8, q3w
Gemcitabine
Drug1.0 g/m2, i.v.,d1, d8, q3w
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Adebrelimab combined with chemotherapy administration groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
R0 removal rate
To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
Time frame
one year2
pCR rate
To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
Time frame
one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jinling Hospital, China
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: