Pancreatic Cancer Metastatic
Conditions
Brief summary
This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
Interventions
IBI363+chemotherapy
Sponsors
Innovent Biologics, Inc.
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent form (ICF) * Age 18-75 years * Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer. * Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel). * ECOG Performance Status(PS) score of 0-1. * At least one measurable lesion according to RECIST v1.1 criteria. * Adequate organ and bone marrow function
Exclusion criteria
* Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc. * Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies. * Unresolved \> Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy). * History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases. * Clinically significant cardiovascular/cerebrovascular diseases * Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Up to approximately 36 months |
| Progression-Free Survival(PFS) | Up to approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Up to approximately 6 months |
| Disease control rate(DCR) | Up to approximately 6 months |
| Overall Survival(OS) | Up to approximately 12 months |
Outcome results
None listed