NCT07312422 LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
| NCT ID | NCT07312422 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-04-30 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-30 with a primary completion date of 2026-04-30.
⚠ 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
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic 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 NCT07312422 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07312422 currently recruiting?
Yes, NCT07312422 is actively recruiting participants. Contact the research team at yangliuqq2003@163.com for enrollment information.
Where is the NCT07312422 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07312422 clinical trial?
NCT07312422 is sponsored by Zhejiang Provincial People's Hospital. The trial plans to enroll 10 participants.
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