Clinical trial · Interventional
LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
An Open-label, Single-center, Single-arm Study to Evaluate the Efficacy and Safety of Low-dose Radiation Therapy Combined With Pultelimab and Standard Treatment in Patients With Advanced Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the activating effect of local lesion low-dose radiotherapy (2Gy) on the tumor immune microenvironment, and the efficacy, safety, and feasibility of its combination with pembrolizumab and standard therapy in patients with advanced pancreatic cancer. Concurrently, to preliminarily establish an efficacy prediction model for the early identification of patient populations who would benefit from the treatment, thereby providing a theoretical foundation for the implementation of precision medicine.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LDRT | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| PD-1 Inhibitor | — | UNRESOLVED | — |
| PD-L1 | — | UNRESOLVED | — |
| Proterizumab | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AG regimen | Drug | — | UNRESOLVED |
| FOLFIRINOX regimen | Drug | — | UNRESOLVED |
| Low-dose Radiotherapy | Radiation | — | UNRESOLVED |
| Pucotenlimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDRT + Pucotenlimab + Chemotherapy
- description
- Patients will receive low-dose radiotherapy (2Gy/1fx) on Day 1 of each cycle. On Day 2, patients will receive Pucotenlimab (200mg IV) combined with standard chemotherapy (investigator's choice of AG regimen or FOLFIRINOX regimen). Treatment cycles differ slightly based on the chemotherapy regimen chosen but are generally repeated every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or up to 2 years.
- interventionNames
- Radiation: Low-dose Radiotherapy
- Biological: Pucotenlimab
- Drug: AG regimen
- Drug: FOLFIRINOX regimen
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 6 weeks
- description
- Overall objective tumor response rate
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years, regardless of gender; * ECOG score of 0 to 1; * Patients with histologically or cytologically confirmed pancreatic malignancy; * No prior treatment with PD-1 or PD-L1 inhibitors; * Presence of a radiotherapeutically eligible target lesion (excluding bone metastases); * Subjects voluntarily participate in the study and provide signed informed consent. Exclusion Criteria: * Previous history of radiotherapy; * Uncontrolled chronic infectious or non-infectious diseases, including but not limited to: medication-refractory heart failure, poorly controlled hypertension, etc.; * Active or clinically uncontrolled severe infections; * History of psychoactive drug abuse that cannot be abstained from, or patients with psychiatric disorders; * Pregnant or lactating women, or patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures; * Other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.
References
Publications (0)
Data not yet available