LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study

Summary

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.

Interventions

• Low-dose Radiotherapy · RADIATION

  Administered on Day 1 of each cycle. A single fraction of 2 Gy (2Gy/1fx) is delivered to the measurable tumor lesion using 3D-CRT or IMRT techniques.

• Pucotenlimab · BIOLOGICAL

  Administered intravenously (200 mg) on Day 2 of each cycle, every 3 weeks (q3w).

• AG regimen · DRUG

  Gemcitabine (1000 mg/m\^2) and Nab-paclitaxel (125 mg/m\^2) administered intravenously on Day 1 and Day 8 of each 3-week cycle.

• FOLFIRINOX regimen · DRUG

  Oxaliplatin (65 mg/m\^2), Irinotecan (140 mg/m\^2), Leucovorin (400 mg/m\^2) on Day 1, followed by 5-FU (2400 mg/m\^2) continuous infusion over 46 hours, every 3 weeks.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China · RECRUITING