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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Low-dose Radiotherapy
  • Pucotenlimab
  • AG regimen
  • FOLFIRINOX regimen

Treatment groups

10 Participants
are divided into 1 treatment group