NCT06050317 Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer
| NCT ID | NCT06050317 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-08-18 |
| Primary Completion | 2025-08-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2023-08-18 with a primary completion date of 2025-08-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
Eligibility Criteria
Inclusion Criteria: * ECOG PS 0-1 * Pathological tissue-confirmed unresectable locally advanced pancreatic cancer * Pancreatic cancer patients who have not received systemic anti-tumor therapy * Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards * A life expectancy of \> 3 months * Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl * AST\<2.5 × ULN(Upper Limit of Normal), ALT\<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin \< ≤1.5 X ULN. Exclusion Criteria: * Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment * Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment * Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors * Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment * Abnormal results of blood routine examinations and liver and kidney and coagulation tests * Abnormal function of major organs (14 days before enrollment) * Women who are pregnant * Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Contact & Investigator
Jinbo Yue, dorctor
PRINCIPAL INVESTIGATOR
Shandong Cancer Hospital and Institute
Frequently Asked Questions
Who can join the NCT06050317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06050317 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06050317 currently recruiting?
Yes, NCT06050317 is actively recruiting participants. Contact the research team at yuejinbo@hotmail.com for enrollment information.
Where is the NCT06050317 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06050317 clinical trial?
NCT06050317 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is Jinbo Yue, dorctor at Shandong Cancer Hospital and Institute. The trial plans to enroll 25 participants.
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