Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI363 + chemotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer Metastatic. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug IBI363 + chemotherapy
IBI363+chemotherapy
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to approximately 36 months]
- Progression-Free Survival(PFS) [Time frame: Up to approximately 6 months]
Secondary outcome measures (3)
- Objective Response Rate (ORR) [Time frame: Up to approximately 6 months]
- Disease control rate(DCR) [Time frame: Up to approximately 6 months]
- Overall Survival(OS) [Time frame: Up to approximately 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07342725 · PANC-IBI363