NCT07342725Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT07342725
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 48
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.